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

NCT07499258 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-05-13

No results posted yet for this study

Summary

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

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Axonics 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.

Sponsors & Collaborators

  • Axonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Keith Chapple, MD · Sheffield Teaching Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499258 on ClinicalTrials.gov