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Tiny tailbone device may calm urgent bathroom trips for colitis patients

NCT ID NCT06571669

Symptom relief Sponsor: Boomerang Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 4 times

Summary

This study tests a small device placed under the skin near the tailbone that sends mild signals to a nerve, aiming to reduce sudden bowel urgency in people with ulcerative colitis. About 137 adults with the condition will take part. The device is implanted in a same-day procedure, and the main goal is to see if it lowers urgency scores after 12 weeks.

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 137 people

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

Started

Jan 2025

Expected to finish

Nov 2027

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: * Male or female * 18 to 85 years of age * Diagnosed with ulcerative colitis * Ability and willingness to consent to participate by signing the informed consent form * Ability to comply with the protocol and willingness to comply with all follow up requirements Exclusion Criteria: * Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study * Any psychiatric or personality disorder at the discretion of the study investigator * Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) * Active clostridium difficile infection of the colon * Active cytomegalovirus (CMV) infection of the colon * Evidence of colonic perforation * Fulminant colitis requiring emergency surgery * Microscopic, ischemic or infectious colitis * Unresected neoplasia of the colon * Colonic stricture unable to pass a colonoscope * Current evidence of cancer in the gastrointestinal tract * Current participation in another clinical trial * Previous history of surgery for ulcerative colitis, or probably to require such intervention * Previously implanted with a neurostimulation device or participated in a neurostimulation trial * Inability to operate the patient programmer

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases Ulcerative colitis

How to take part

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

  1. The places running it

    17 sites. 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

  • Amarillo Premier Research (Objective Health)

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Center for Colorectal Innovation

    RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia Digestive Health Research (Objective Health)

    RECRUITING

    Columbia, South Carolina, 29204, United States

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Digestive Health Research of North Texas (Objective Health)

    ACTIVE_NOT_RECRUITING

    Wichita Falls, Texas, 76301, United States

  • Digestive Research of Central Texas (Objective Health)

    RECRUITING

    Waco, Texas, 76712, United States

  • GI Alliance

    RECRUITING

    Jackson, Mississippi, 39232, United States

  • Gastroenterology Medical Clinic (Objective Health)

    RECRUITING

    Folsom, California, 95630, United States

  • Gateway GI Research (Objective Health)

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Great Lakes Gastro

    WITHDRAWN

    Mentor, Ohio, 44060, United States

  • Hoag Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Kansas Gastro

    RECRUITING

    Wichita, Kansas, 67226-8119, United States

  • Las Vegas Medical Research LLC, DBA Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • MN Urology

    RECRUITING

    Woodbury, Minnesota, 55125, United States

  • Northwell Health North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • PAMF (Palo Alto Medical Foundation)

    RECRUITING

    Palo Alto, California, 94301, United States

  • Pennsylvania Hospital

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Sanford Health

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • UNC Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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Other studies related to the condition(s) this trial covers.