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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05396131




Registration number
NCT05396131
Ethics application status
Date submitted
20/09/2021
Date registered
31/05/2022

Titles & IDs
Public title
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Scientific title
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
Secondary ID [1] 0 0
AI-MCVP-COPD-ELVR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Lung Sealant
Treatment: Devices - Endobronchial Valve (EBV)

Active comparator: Collateral Ventilation Negative - Collateral Ventilation Negative participants will have endobronchial valve implant

Experimental: Collateral Ventilation Positive - Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant


Treatment: Devices: Lung Sealant
The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.

Treatment: Devices: Endobronchial Valve (EBV)
The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
Timepoint [1] 0 0
4 weeks post lung sealant application
Secondary outcome [1] 0 0
Number of participants with improved lung functioning as measured by lung function tests
Timepoint [1] 0 0
12weeks and 52 weeks post valve implant
Secondary outcome [2] 0 0
Changes Lung volume
Timepoint [2] 0 0
12weeks and 52 weeks post valve implant

Eligibility
Key inclusion criteria
* i. 18-85 years of age
* ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
* iii. Residual Volume (RV) > 175%
* iv. 6 min walk test > 150 m
* v. Completed a course of Pulmonary rehabilitation
* vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
* vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
* ii. Acute respiratory tract infections
* iii. Significant bronchiectasis,
* iv. Co-existing interstitial lung diseases, pneumothorax,
* v. Known active malignancy
* vi. Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2022
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alvin J Ing, MBBS, MD, FRACP
Address 0 0
Clinical Professor and Respiratory Physician
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05396131