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New implant aims to control bowel leakage

NCT ID NCT07499258

Disease control Sponsor: Axonics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This study is testing a rechargeable device that sends mild electrical pulses to nerves in the lower back to help people with fecal incontinence (unexpected bowel leakage). About 55 adults will get the implant and be followed for 2 years. The goal is to see if the device improves quality of life and patient satisfaction.

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.

Participants

About 55 people

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

Started

Jul 2026

Expected to finish

Jun 2028

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.

Who is studied

Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.

Ages

18 years and older

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: 1. 18 years or older 2. Primary indication of Fecal Incontinence (FI) 3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Female Urology of Nashville Research Partnership

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Houston Colon

    RECRUITING

    Houston, Texas, 77030, United States

  • Northern General Hospital

    NOT_YET_RECRUITING

    Sheffield, United Kingdom

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