NCT07499258Recruiting
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Axonics, Inc.
Start Date
7/2/2026
Completion Date
6/1/2028
Summary
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Detailed Description
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DEVICE
Axonics SNM System INS Model 5101 (R20)
Conditions
Fecal Incontinence
Locations
Columbia University Medical Center
New York, New York 10032
United States
The Christ Hospital
Cincinnati, Ohio 45219
United States
Female Urology of Nashville Research Partnership
Nashville, Tennessee 37209
United States
Houston Colon
Houston, Texas 77030
United States
Northern General Hospital
Sheffield,
United Kingdom