NCT07499258

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Axonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-01
• Completion: 2029-12-30
• First posted: 2026-03-30
• Last updated: 2026-04-15

Regulatory

• FDA-regulated device study