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Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

Recruitingn/aAges 18 Years - anyAllAxonics, Inc.
NCT07499258 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.

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📋 Eligibility rules (as published)
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
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What it tests

  • Axonics SNM System INS Model 5101 (R20)
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Where

5 sites
Columbia University Medical Center
New York, United States
The Christ Hospital
Cincinnati, United States
Female Urology of Nashville Research Partnership
Nashville, United States
Houston Colon
Houston, United States
Northern General Hospital
Sheffield, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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