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Recruiting NCT07499258

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

Conditions: Fecal Incontinence

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 55
Sponsor: Axonics, Inc.

Location: Columbia University Medical Center New York New York

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07499258). StuddyBuddy aggregates publicly available trial information.