NCT07499258 Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
| NCT ID | NCT07499258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Axonics, Inc. |
| Condition | Fecal Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2026-07-02 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2026-07-02 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Eligibility Criteria
Inclusion Criteria: 1. 18 years or older 2. Primary indication of Fecal Incontinence (FI) 3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test
Contact & Investigator
Keith Chapple, MD
PRINCIPAL INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07499258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07499258 currently recruiting?
Yes, NCT07499258 is actively recruiting participants. Contact the research team at caroline.beaudoint@bsci.com for enrollment information.
Where is the NCT07499258 trial being conducted?
This trial is being conducted at New York, United States, Cincinnati, United States, Nashville, United States, Houston, United States and 2 additional locations.
Who is sponsoring the NCT07499258 clinical trial?
NCT07499258 is sponsored by Axonics, Inc.. The principal investigator is Keith Chapple, MD at Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 55 participants.