Trials / Recruiting
RecruitingNCT06789406
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Axonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Detailed description
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
Conditions
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
- 2025-09-18
- Primary completion
- 2027-01-01
- Completion
- 2031-10-01
- First posted
- 2025-01-23
- Last updated
- 2026-04-15
Locations
4 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06789406. Inclusion in this directory is not an endorsement.