Actively Recruiting
Post-Market Follow-Up of the Rechargeable Axonics SNM System Model 5101 for Adults with Fecal Incontinence
Led by Axonics, Inc. · Updated on 2026-08-12
55
Participants Needed
2
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
This research evaluates the safety and performance of the commercially available rechargeable Axonics SNM System Model 5101 R20 in participants diagnosed with fecal incontinence. The study is a single-arm, multi-center, prospective, open-label registry designed to collect post-market clinical follow-up data on this implantable neurostimulator. Participants receive the Axonics SNM System Model 5101 device, which is used according to the approved instructions for use in each region. The study focuses on individuals eligible for this rechargeable device and monitors their fecal incontinence symptoms over time. During the study, participants will be followed up for improvements in quality of life and patient satisfaction related to fecal incontinence, measured at 3, 12, and 24 months. Researchers will also monitor adverse events for safety throughout these periods. The study involves regular evaluations at selected clinical centers to assess ongoing device performance and participant well-being.
CONDITIONS
Brief Title
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Research Team
C
Caroline Beaudoint
G
Gita Ghadimi, OD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
