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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05854550
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05854550
Ethics application status
Date submitted
20/04/2023
Date registered
11/05/2023
Titles & IDs
Public title
First in Human Study to Assess an Implant to Treat Severe Emphysema
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Scientific title
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung
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Secondary ID [1]
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CIP-0001
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Universal Trial Number (UTN)
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Trial acronym
BREATHE-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Emphysema or COPD
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Apreo Implant Group
Experimental: Apreo Implant Group - This group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.
Treatment: Devices: Apreo Implant Group
One or two procedures involving placement of up to three Apreo implants in the bronchial tree of each lung.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Serious Adverse Events (SAE) at 6 Months
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Assessment method [1]
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Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure
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Timepoint [1]
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6 Months
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Secondary outcome [1]
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Device Evaluation: Device Deployment Assessment
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Assessment method [1]
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Evaluation of the ability to deploy the Apreo Implant in target airways (There is no scale - questions are assessed individually)
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Timepoint [1]
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During Procedure
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Secondary outcome [2]
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Device Evaluation: Device Usability Survey
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Assessment method [2]
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Evaluate operator device use challenges (There is no scale - questions are assessed individually)
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Timepoint [2]
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During Procedure
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Secondary outcome [3]
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Device Evaluation: Instructions for Use (IFU) Survey
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Assessment method [3]
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Evaluate operator understanding of instructions for use (There is no scale - questions are assessed individually)
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Timepoint [3]
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During Procedure
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Secondary outcome [4]
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Efficacy Evaluation: Airway Patency at 30 Days
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Assessment method [4]
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Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= \>75% to 100% narrowing)
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Timepoint [4]
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30 Days
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Secondary outcome [5]
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Efficacy Evaluation: Airway Patency at 3 Months
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Assessment method [5]
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Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= \>75% to 100% narrowing)
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Timepoint [5]
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3 Months
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Secondary outcome [6]
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Efficacy Evaluation: Airway Patency at 6 Months
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Assessment method [6]
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Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= \>75% to 100% narrowing)
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Timepoint [6]
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6 Months
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Secondary outcome [7]
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Efficacy Evaluation: Airway Patency at 12 Months
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Assessment method [7]
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Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= \>75% to 100% narrowing)
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Timepoint [7]
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12 Months
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Secondary outcome [8]
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Efficacy Evaluation: Mucus Assessment at 30 Days
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Assessment method [8]
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Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
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Timepoint [8]
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30 Days
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Secondary outcome [9]
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Efficacy Evaluation: Mucus Assessment at 3 Months
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Assessment method [9]
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Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
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Timepoint [9]
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3 Months
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Secondary outcome [10]
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Efficacy Evaluation: Mucus Assessment at 6 Months
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Assessment method [10]
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Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
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Timepoint [10]
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6 Months
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Secondary outcome [11]
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Efficacy Evaluation: Mucus Assessment at 12 Months
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Assessment method [11]
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Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
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Timepoint [11]
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12 Months
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Secondary outcome [12]
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Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months
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Assessment method [12]
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0
CT evaluation of Apreo Implant diameter
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Timepoint [12]
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6 Months
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Secondary outcome [13]
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Efficacy Evaluation: CT Scan at 12 Months
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Assessment method [13]
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CT evaluation of Apreo Implant diameter
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Timepoint [13]
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12 Months
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Secondary outcome [14]
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Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days
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Assessment method [14]
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Change in FEV1 between Baseline and 1-3 days post-procedure
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Timepoint [14]
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1-3 Days
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Secondary outcome [15]
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Efficacy Evaluation: FEV1 at 30 Days
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Assessment method [15]
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Change in FEV1 between Baseline and 30 days post-procedure
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Timepoint [15]
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30 Days
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Secondary outcome [16]
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Efficacy Evaluation: FEV1 at 3 Months
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Assessment method [16]
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Change in FEV1 between Baseline and 3 months post-procedure
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Timepoint [16]
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3 Months
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Secondary outcome [17]
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Efficacy Evaluation: FEV1 at 6 Months
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Assessment method [17]
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Change in FEV1 between Baseline and 6 months post-procedure
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Timepoint [17]
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6 Months
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Secondary outcome [18]
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Efficacy Evaluation: FEV1 at 12 Months
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Assessment method [18]
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Change in FEV1 between Baseline and 12 months post-procedure
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Timepoint [18]
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12 Months
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Secondary outcome [19]
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Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months
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Assessment method [19]
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Change in DLCO between baseline and 6 months post-procedure
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Timepoint [19]
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6 Months
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Secondary outcome [20]
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Efficacy Evaluation: Residual Volume (RV) at 6 Months
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Assessment method [20]
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Change in RV between baseline and 6 months as assessed by quantitative CT
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Timepoint [20]
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6 Months
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Secondary outcome [21]
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0
Efficacy Evaluation: Residual Volume (RV) at 12 Months
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Assessment method [21]
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Change in RV between baseline and 12 months as assessed by quantitative CT
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Timepoint [21]
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12 Months
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Secondary outcome [22]
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Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months
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Assessment method [22]
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Change in PaO2 between baseline and 6 months
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Timepoint [22]
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6 Months
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Secondary outcome [23]
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Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months
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Assessment method [23]
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Change in PaCO2 between baseline and 6 months
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Timepoint [23]
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6 Months
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Secondary outcome [24]
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Safety: Procedural Complications
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Assessment method [24]
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Percentage of participants with acute procedural complications within 24 hours of study procedure
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Timepoint [24]
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Through 24 hours post-procedure
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Secondary outcome [25]
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Safety: Rate of SAEs
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Assessment method [25]
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Rate of occurrence of serious adverse events related to the device and/or Apreo procedure through 12 months
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Timepoint [25]
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Through 12 Months
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Secondary outcome [26]
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Safety: Rate of Adverse Device Effects
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Assessment method [26]
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0
Rate of adverse device effects through 12 months post-procedure
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Timepoint [26]
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Through 12 Months
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Secondary outcome [27]
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Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days
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Assessment method [27]
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Change in FEV1/FVC between Baseline and 1-3 days post-procedure
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Timepoint [27]
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1-3 Days
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Secondary outcome [28]
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Efficacy Evaluation: FEV1/FVC at 30 Days
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Assessment method [28]
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0
Change in FEV1/FVC between Baseline and 30 days post-procedure
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Timepoint [28]
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30 Days
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Secondary outcome [29]
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Efficacy Evaluation: FEV1/FVC at 3 Months
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Assessment method [29]
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Change in FEV1/FVC between Baseline and 3 Months post-procedure
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Timepoint [29]
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3 Months
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Secondary outcome [30]
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Efficacy Evaluation: FEV1/FVC at 6 Months
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Assessment method [30]
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0
Change in FEV1/FVC between Baseline and 6 Months post-procedure
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Timepoint [30]
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6 Months
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Secondary outcome [31]
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0
Efficacy Evaluation: FEV1/FVC at 12 Months
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Assessment method [31]
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0
Change in FEV1/FVC between Baseline and 12 Months post-procedure
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Timepoint [31]
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0
12 Months
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Secondary outcome [32]
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0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days
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Assessment method [32]
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0
Change in RV between Baseline and 1-3 Days
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Timepoint [32]
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0
1-3 Days
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Secondary outcome [33]
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0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days
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Assessment method [33]
0
0
Change in RV between Baseline and 30 Days
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Timepoint [33]
0
0
30 Days
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Secondary outcome [34]
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0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months
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Assessment method [34]
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0
Change in RV between Baseline and 3 Months
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Timepoint [34]
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0
3 Months
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Secondary outcome [35]
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0
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months
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Assessment method [35]
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0
Change in RV between Baseline and 6 Months
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Timepoint [35]
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6 Months
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Secondary outcome [36]
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Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months
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Assessment method [36]
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Change in RV between Baseline and 12 Months
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Timepoint [36]
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12 Months
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Secondary outcome [37]
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Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days
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Assessment method [37]
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Change in RV/TLC between Baseline and 1-3 Days
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Timepoint [37]
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1-3 Days
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Secondary outcome [38]
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Efficacy Evaluation: RV/TLC at 30 Days
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Assessment method [38]
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Change in RV/TLC between Baseline and 30 Days
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Timepoint [38]
0
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30 Days
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Secondary outcome [39]
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Efficacy Evaluation: RV/TLC at 3 Months
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Assessment method [39]
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Change in RV/TLC between Baseline and 3 Months
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Timepoint [39]
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3 Months
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Secondary outcome [40]
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Efficacy Evaluation: RV/TLC at 6 Months
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Assessment method [40]
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Change in RV/TLC between Baseline and 6 Months
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Timepoint [40]
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6 Months
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Secondary outcome [41]
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Efficacy Evaluation: RV/TLC at 12 Months
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Assessment method [41]
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Change in RV/TLC between Baseline and 12 Months
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Timepoint [41]
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12 Months
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Secondary outcome [42]
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Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days
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Assessment method [42]
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Change in FVC between Baseline and 1-3 Days
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Timepoint [42]
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1-3 Days
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Secondary outcome [43]
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Efficacy Evaluation: FVC at 30 Days
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Assessment method [43]
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Change in FVC between Baseline and 30 Days
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Timepoint [43]
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30 Days
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Secondary outcome [44]
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Efficacy Evaluation: FVC at 3 Months
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Assessment method [44]
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Change in FVC between Baseline and 3 Months
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Timepoint [44]
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3 Months
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Secondary outcome [45]
0
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Efficacy Evaluation: FVC at 6 Months
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Assessment method [45]
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Change in FVC between Baseline and 6 Months
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Timepoint [45]
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6 Months
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Secondary outcome [46]
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Efficacy Evaluation: FVC at 12 Months
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Assessment method [46]
0
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Change in FVC between Baseline and 12 Months
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Timepoint [46]
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12 Months
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Secondary outcome [47]
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Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days
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Assessment method [47]
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Change in 6MWT between Baseline and 1-3 Days
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Timepoint [47]
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1-3 Days
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Secondary outcome [48]
0
0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days
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Assessment method [48]
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0
Change in 6MWT between Baseline and 30 Days
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Timepoint [48]
0
0
30 Days
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Secondary outcome [49]
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Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months
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Assessment method [49]
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0
Change in 6MWT between Baseline and 3 Months
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Timepoint [49]
0
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3 Months
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Secondary outcome [50]
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Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months
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Assessment method [50]
0
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Change in 6MWT between Baseline and 6 Months
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Timepoint [50]
0
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6 Months
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Secondary outcome [51]
0
0
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months
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Assessment method [51]
0
0
Change in 6MWT between Baseline and 12 Months
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Timepoint [51]
0
0
12 Months
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Secondary outcome [52]
0
0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days
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Assessment method [52]
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Change in Modified BORG Dyspnea Scale between Baseline and 1-3 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
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Timepoint [52]
0
0
1-3 Days
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Secondary outcome [53]
0
0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days
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Assessment method [53]
0
0
Change in Modified BORG Dyspnea Scale between Baseline and 30 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
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Timepoint [53]
0
0
30 Days
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Secondary outcome [54]
0
0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months
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Assessment method [54]
0
0
Change in Modified BORG Dyspnea Scale between Baseline and 3 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
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Timepoint [54]
0
0
3 Months
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Secondary outcome [55]
0
0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months
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Assessment method [55]
0
0
Change in Modified BORG Dyspnea Scale between Baseline and 6 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
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Timepoint [55]
0
0
6 Months
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Secondary outcome [56]
0
0
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months
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Assessment method [56]
0
0
Change in Modified BORG Dyspnea Scale between Baseline and 12 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
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Timepoint [56]
0
0
12 Months
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Secondary outcome [57]
0
0
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
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Assessment method [57]
0
0
Change in CAT between Baseline and 1-3 Days
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Timepoint [57]
0
0
1-3 Days
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Secondary outcome [58]
0
0
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
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Assessment method [58]
0
0
Change in CAT between Baseline and 30 Days
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Timepoint [58]
0
0
30 Days
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Secondary outcome [59]
0
0
Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
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Assessment method [59]
0
0
Change in CAT between Baseline and 3 Months
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Timepoint [59]
0
0
3 Months
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Secondary outcome [60]
0
0
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
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Assessment method [60]
0
0
Change in CAT between Baseline and 6 Months
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Timepoint [60]
0
0
6 Months
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Secondary outcome [61]
0
0
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
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Assessment method [61]
0
0
Change in CAT between Baseline and 12 Months
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Timepoint [61]
0
0
12 Months
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Secondary outcome [62]
0
0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
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Assessment method [62]
0
0
Change in SGRQ-C between Baseline and 1-3 Days
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Timepoint [62]
0
0
1-3 Days
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Secondary outcome [63]
0
0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
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Assessment method [63]
0
0
Change in SGRQ-C between Baseline and 30 Days
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Timepoint [63]
0
0
30 Days
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Secondary outcome [64]
0
0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
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Assessment method [64]
0
0
Change in SGRQ-C between Baseline and 3 Months
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Timepoint [64]
0
0
3 Months
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Secondary outcome [65]
0
0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
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Assessment method [65]
0
0
Change in SGRQ-C between Baseline and 6 Months
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Timepoint [65]
0
0
6 Months
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Secondary outcome [66]
0
0
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
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Assessment method [66]
0
0
Change in SGRQ-C between Baseline and 12 Months
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Timepoint [66]
0
0
12 Months
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Secondary outcome [67]
0
0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days
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Assessment method [67]
0
0
Change in mMRC between Baseline and 1-3 Days
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Timepoint [67]
0
0
1-3 Days
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Secondary outcome [68]
0
0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days
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Assessment method [68]
0
0
Change in mMRC between Baseline and 30 Days
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Timepoint [68]
0
0
30 Days
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Secondary outcome [69]
0
0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months
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Assessment method [69]
0
0
Change in mMRC between Baseline and 3 Months
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Timepoint [69]
0
0
3 Months
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Secondary outcome [70]
0
0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months
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Assessment method [70]
0
0
Change in mMRC between Baseline and 6 Months
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Timepoint [70]
0
0
6 Months
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Secondary outcome [71]
0
0
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months
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Assessment method [71]
0
0
Change in mMRC between Baseline and 12 Months
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Timepoint [71]
0
0
12 Months
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Eligibility
Key inclusion criteria
1. Age = 35 and = 80 years old
2. Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
3. At least one target lobe with > 35% destruction (percent of voxels with < -950 Hounsfield units on CT)
4. Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening
5. Post-bronchodilator FEV1 percent predicted =20% and =50% of predicted at screening
6. Post-bronchodilator RV > 180% predicted
7. Post-bronchodilator RV/TLC = 0.55 at screening
8. Marked dyspnea, scoring = 2 on the modified Medical Research Council scale of 0-4
9. Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation
10. Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study
11. Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance)
12. Cognitively and physically able to provide written informed consent and complete participant questionnaires
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Minimum age
35
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 = 45 mmHg (6 kPa)
2. DLCO <20% at screening
3. Steroid therapy of 10 mg prednisolone (prednisone) or more per day
4. Three or more acute exacerbations of COPD in the past year before enrollment
5. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
6. Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
7. Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
8. Known history of pulmonary arterial hypertension
9. Presence of a giant bulla (= 30% of hemithorax)
10. History of excessive dynamic airway collapse of the trachea or main bronchi
11. History of adult asthma or chronic bronchitis
12. Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
13. Unequivocal and symptomatic bronchiectasis
14. Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
15. Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure
16. Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding
17. On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure
18. Coronary artery disease with angina
19. History of myocardial infarction within 6 months
20. History of a stroke less than 1 year before the first Apreo Procedure
21. Clinical history of heart failure with documented LVEF = 40%
22. Clinical history of diabetes with a HbA1c > 9.0%
23. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease)
24. Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device
25. Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration
26. Known hypersensitivity to nitinol
27. Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
28. Any disease or condition likely to limit survival to less than one year
29. Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure
30. Currently enrolled in another trial and actively receiving experimental treatment
31. Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
Macquarie University Hospital - Macquarie
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Recruitment hospital [2]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
0
0
2109 - Macquarie
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Recruitment postcode(s) [2]
0
0
3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Apreo Health, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
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Trial website
https://clinicaltrials.gov/study/NCT05854550
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Shirin Hasan
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Address
0
0
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Country
0
0
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Phone
0
0
+1 408-250-5881
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05854550
Additional trial details provided through ANZCTR
Accrual to date
3
Recruiting in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1]
141
Royal Melbourne Hospital - City campus
Recruitment hospital [2]
142
Macquarie University
Recruitment postcode(s) [1]
142
2109
Recruitment postcode(s) [2]
143
3050
Funding & Sponsors
Funding source category [1]
85
Commercial sector/Industry
Name [1]
85
Apreo Health Australia Pty Ltd
Address [1]
85
c/o Prime Accounting # Business Advisory ‘HWT Tower’ Level 17, 40 City Road, Southbank, VIC 3006
Country [1]
85
Australia
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Apreo Health Australia Pty Ltd
Primary sponsor address
c/o Prime Accounting # Business Advisory ‘HWT Tower’ Level 17, 40 City Road, Southbank, VIC 3006
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
62
Macquarie University HREC
Address [1]
62
Balaclava Road, North Ryde New South Wales 2109
Country [1]
62
Australia
Date submitted for ethics approval [1]
62
13/02/2023
Approval date [1]
62
23/02/2023
Ethics approval number [1]
62
Reference No:520231304946439
Ethics committee name [2]
63
Royal Melbourne Hospital HREC
Address [2]
63
300 Grattan Street Parkville, VIC 3050
Country [2]
63
Australia
Date submitted for ethics approval [2]
63
29/11/2022
Approval date [2]
63
23/03/2023
Ethics approval number [2]
63
HREC Reference Number: HREC/91821/MH-2022
Public notes
Contacts
Principal investigator
Title
389
0
A/Prof
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Name
389
0
Daniel Steinfort
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Address
389
0
Royal Melbourne Hospital - City Campus 300 Grattan Street Parkville, VIC 3050
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Country
389
0
Australia
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Phone
389
0
+61416275750
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Fax
389
0
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Email
389
0
[email protected]
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Contact person for public queries
Title
390
0
Mr
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Name
390
0
Matt Godden
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Address
390
0
Level 1 / 424 Burke Road Camberwell, VIC 3124
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Country
390
0
Australia
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Phone
390
0
+61400007127
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Fax
390
0
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Email
390
0
[email protected]
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Contact person for scientific queries
Title
391
0
A/Prof
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Name
391
0
Daniel Steinfort
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Address
391
0
Royal Melbourne Hospital - City Campus 300 Grattan Street Parkville, VIC 3050
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Country
391
0
Australia
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Phone
391
0
+61416275750
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Fax
391
0
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Email
391
0
[email protected]
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