Trials / Active Not Recruiting
Active Not RecruitingNCT05708612
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Medical Device (SimplyFI) | Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2026-04-01
- Completion
- 2026-09-01
- First posted
- 2023-02-01
- Last updated
- 2026-03-20
Locations
5 sites across 3 countries: Austria, Germany, Spain
Source: ClinicalTrials.gov record NCT05708612. Inclusion in this directory is not an endorsement.