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

> **NCT05708612** · NA · ACTIVE_NOT_RECRUITING · sponsor: **A.M.I. Agency for Medical Innovations GmbH** · enrollment: 36 (estimated)

## Conditions studied

- Fecal Incontinence

## Interventions

- **PROCEDURE:** Medical Device (SimplyFI)

## Key facts

- **NCT ID:** NCT05708612
- **Lead sponsor:** A.M.I. Agency for Medical Innovations GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-04-01
- **Primary completion:** 2026-04
- **Final completion:** 2026-09
- **Target enrollment:** 36 (ESTIMATED)
- **Last updated:** 2026-03-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05708612

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05708612, "Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)". Retrieved via AI Analytics 2026-07-05 from https://api.ai-analytics.org/clinical/NCT05708612. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*