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New silicone implant aims to treat fecal incontinence

NCT ID NCT05708612

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Both male and female subjects * Age ≥ 18 years, \<85 years * Subject has failed standard conservative therapy for fecal incontinence (at least 6 months) * Subject is a surgical candidate * Subject is willing and able to cooperate with follow-up examinations * Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes. Exclusion Criteria: * Treatment with another investigational drug or investigational device * Unable to understand study requirements or is unable to comply with follow-up schedule * Contraindicated according to the instruction for use of the device * Pregnancy or nursing, or plans to become pregnant * History of significant obstructed defecation or other significant chronic defecatory motility disorders * Current, external full thickness rectal prolapse or vaginal prolapse * Inflammatory Bowel Disease * Irritable Bowel Syndrome * Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's) * Active pelvic infection * Chronic diarrhea * Medical history of anal, rectal, or colon cancer * Prior anterior resection of the rectum * Medical history of pelvic radiation therapy * Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula * Previous anorectal posterior compartment surgery * History of complex anal fistula

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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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