Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Ou… (NCT04754477) | Clinical Trial Compass
CompletedNot Applicable
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Australia, Hong Kong20 participantsStarted 2021-05-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and Type of Reported Adverse Events
Timeframe: 6 months post-surgery to 24 months post-surgery
2
Number and Type of Reported Device Deficiencies
Timeframe: 6 months post-surgery to 24 months post-surgery
3
Concomitant Medication Used
Timeframe: 6 months post-surgery to 24 months post-surgery
4
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timeframe: 12 months post-surgery
5
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timeframe: 24 months post-surgery
6
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
Timeframe: Baseline before surgery, 12 months and 24 months post-surgery