Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence (NCT07499258)
Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)
🩺 Plain-English Summary (8th-Grade Level)
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Who can join: Review the eligibility criteria below.
Location: Columbia University Medical Center — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Columbia University Medical Center — New York, New York
- Houston Colon — Houston, Texas
📞 Contact the Study Coordinator
Phone: +32 (0) 479 90.41.63
Email: caroline.beaudoint@bsci.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fecal Incontinence
- Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury — La Jolla, California
- Use of the LEVA® Pelvic Health System for Fecal Incontinence — Madison, Wisconsin
- Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence — Richmond, Virginia
- Autologous Muscle Fiber Fragment Injections — Winston-Salem, North Carolina
- Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury — Cleveland, Ohio
- Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence — Augusta, Georgia
Explore by condition: All Fecal Incontinence clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.