New silicone implant aims to treat fecal incontinence

NCT ID NCT05708612

Ongoing Disease control Sponsor: A.M.I. Agency for Medical Innovations GmbH Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a silicone implant called SimplyFI to treat chronic fecal incontinence in people who haven't gotten better with standard treatments. The implant is placed during a procedure and aims to improve bowel control. Researchers are checking how safe it is and how well it works over 12 months in 36 adults.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: silicone implant (SimplyFI)
What this could lead to: If successful, this implant could offer a new, less invasive surgical option to help control fecal incontinence and improve quality of life.
What could go wrong: This is a small, early-stage study with only 36 participants. The implant may cause complications or not work for everyone, and long-term results are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FECAL INCONTINENCE

Contacts and locations

Locations

Göttlicher Heiland Krankenhaus

Vienna, Austria
Hospital Ruber Internacional

Madrid, Spain
Hospital Universitario Ramón y Cajal

Madrid, Spain
Klinikum Bielefeld Rosenhöhe

Bielefeld, Germany
Medical University Vienna

Vienna, Austria

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