Clinical Trial

Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 20, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-01-23; most recent amendment 2026-03-18.
Status change: Recruiting → Active, Not Recruiting 2026-03-18
Status change: Not Yet Recruiting → Recruiting 2023-04-03
Trial Details
NCT Number NCT05708612
Lead Sponsor A.M.I. Agency for Medical Innovations GmbH
Conditions Fecal Incontinence
Enrollment 36 participants
Start Date 2023-04-01
Primary Completion 2026-04 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-20