Trials / Active Not Recruiting
Active Not RecruitingNCT06186765
F15 Recharge Free Axonics SNM System Clinical Study
Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Axonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
Detailed description
A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Axonics SNM System (Model 4101) | Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI). |
Timeline
- Start date
- 2023-12-08
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-01-02
- Last updated
- 2026-04-15
Locations
16 sites across 3 countries: United States, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06186765. Inclusion in this directory is not an endorsement.