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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04754477
Registration number
NCT04754477
Ethics application status
Date submitted
10/02/2021
Date registered
15/02/2021
Titles & IDs
Public title
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
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Scientific title
A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
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Secondary ID [1]
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CBAS5793
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Active Osseointegrated Steady-State Implant System (OSI)
Experimental: Active Osseointegrated Steady-State Implant System (OSI) -
Treatment: Devices: Active Osseointegrated Steady-State Implant System (OSI)
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
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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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Number and Type of Reported Adverse Events
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Assessment method [1]
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The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
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Timepoint [1]
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6 months post-surgery to 24 months post-surgery
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Primary outcome [2]
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Number and Type of Reported Device Deficiencies
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Assessment method [2]
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The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
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Timepoint [2]
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6 months post-surgery to 24 months post-surgery
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Primary outcome [3]
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Concomitant Medication Used
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Assessment method [3]
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Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
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Timepoint [3]
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6 months post-surgery to 24 months post-surgery
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Primary outcome [4]
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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
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Assessment method [4]
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Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
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Timepoint [4]
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12 months post-surgery
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Primary outcome [5]
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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
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Assessment method [5]
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Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
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Timepoint [5]
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24 months post-surgery
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Primary outcome [6]
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Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram
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Assessment method [6]
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Bone- and air conduction thresholds, masked and unmasked
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Timepoint [6]
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Baseline before surgery, 12 months and 24 months post-surgery
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Secondary outcome [1]
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Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
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Assessment method [1]
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Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)
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Timepoint [1]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [2]
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Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
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Assessment method [2]
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Sound-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
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Timepoint [2]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [3]
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Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise
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Assessment method [3]
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Speech-to-noise ratio, 50% speech understanding
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Timepoint [3]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [4]
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Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct
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Assessment method [4]
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BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
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Timepoint [4]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [5]
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Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [5]
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Assessed via Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. APHAB produces a global score and scores for four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. Global score is the average of all subscales. All scales range from 0-100%, where 0% indicates no problem and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The difference in scores will be presented. A positive value indicates an improvement, a negative value an impairment.
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Timepoint [5]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [6]
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Change in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [6]
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Assessed via the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Measuring change of speech, spatial and hearing experiences with the Active Osseointegrated Steady-State Implant System. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". An increase of an SSQ value reflects an improvement. The change in scores will be presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
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Timepoint [6]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [7]
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Change in Health-related Quality of Life With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [7]
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Assessed via the Health Utilities Index (HUI) questionnaire. Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index when wearing the Active Osseointegrated Steady-State Implant System. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
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Timepoint [7]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [8]
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Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
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Assessment method [8]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
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Timepoint [8]
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12 months post-surgery
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Secondary outcome [9]
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Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
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Assessment method [9]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
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Timepoint [9]
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12 months post-surgery
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Secondary outcome [10]
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Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
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Assessment method [10]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
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Timepoint [10]
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12 months post-surgery
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Secondary outcome [11]
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Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
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Assessment method [11]
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Timepoint [11]
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12 months post-surgery
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Secondary outcome [12]
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Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
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Assessment method [12]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
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Timepoint [12]
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24 months post-surgery
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Secondary outcome [13]
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Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
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Assessment method [13]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
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Timepoint [13]
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24 months post-surgery
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Secondary outcome [14]
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Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
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Assessment method [14]
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To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
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Timepoint [14]
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24 months post-surgery
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Secondary outcome [15]
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Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
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Assessment method [15]
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Timepoint [15]
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24 months post-surgery
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Secondary outcome [16]
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Daily Use of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [16]
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Average hours of daily use during the last week before each follow up visit
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Timepoint [16]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [17]
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Daily Streaming Time of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [17]
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Average hours of daily streaming during the last week before each follow up visit
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Timepoint [17]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [18]
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Battery Lifetime of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [18]
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Average hours of battery lifetime for a single battery during the last week before each follow up visit
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Timepoint [18]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [19]
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Magnet Choice of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [19]
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Magnet strength ranging from 1 to 4, strength 1 being the weakest and 4 the strongest. If the magnet strength has been changed the reason for change is captured in free text
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Timepoint [19]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [20]
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Use of SoftWear Pad for the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [20]
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SoftWear pad usage: Yes or No
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Timepoint [20]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [21]
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Retention of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [21]
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Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.
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Timepoint [21]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Secondary outcome [22]
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Wearing Comfort of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
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Assessment method [22]
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Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.
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Timepoint [22]
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3 or 6 months post-surgery, 12 and 24 months post-surgery
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Eligibility
Key inclusion criteria
* Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
* Willing and able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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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
* Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
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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
Completed
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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
6/05/2021
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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
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Actual
21/03/2022
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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SCIC / NextSense - Gladesville
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Recruitment hospital [2]
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HEARnet Clinical studies - Carlton
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Recruitment postcode(s) [1]
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2111 - Gladesville
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cochlear
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Statistiska Konsultgruppen
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.
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Trial website
https://clinicaltrials.gov/study/NCT04754477
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Karin Ganlöv, MD
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Address
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Cochlear
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/77/NCT04754477/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/77/NCT04754477/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04754477