FENIX™ Continence Restoration System Registry (NCT04007250) | Clinical Trial Compass
CompletedNot Applicable
FENIX™ Continence Restoration System Registry
France, Germany94 participantsStarted 2012-01-07
Plain-language summary
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
Who can participate
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:
* Individuals being treated with the FENIX™ Continence Restoration System
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
* Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.
Exclusion Criteria:
* Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy \<5 years)
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
Change in fecal incontinence (FI) episodes
Timeframe: Evaluate at 6 months and then annually at 12 months through 60 months post implant
2
Change in fecal incontinence days
Timeframe: Evaluate at 6 months and then annually at 12 months through 60 months post implant
3
Adverse events related to the FENIX system
Timeframe: assessed up to last follow up [max 60 months]
4
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.
Timeframe: Evaluate at 6 months and then annually at 12 months through 60 months post implant