RecruitingNCT07499258

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

Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)

Sponsor

Axonics, Inc.

Enrollment

55 participants

Start Date

Jul 2, 2026

Study Type

OBSERVATIONAL

Conditions

Fecal Incontinence

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Axonics SNM System INS Model 5101 (R20) for people with fecal incontinence. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAxonics SNM System INS Model 5101 (R20)

Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.