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NCT06571669NARecruiting

BOOM-IBD2 Pivotal Clinical Trial

Boomerang Medical

Start Date

1/31/2025

Completion Date

11/30/2027

Summary

Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.

Detailed Description

The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

Neuromodulation

Interested in This Trial?

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Conditions

Ulcerative ColitisInflammatory Bowel Diseases

Locations

Gastroenterology Medical Clinic (Objective Health)

Folsom, California 95630

United States

Center for Colorectal Innovation

Los Angeles, California 90048

United States

Hoag Hospital

Newport Beach, California 92663

United States

PAMF (Palo Alto Medical Foundation)

Palo Alto, California 94301

United States

Kansas Gastro

Wichita, Kansas 67226-8119

United States

MN Urology

Woodbury, Minnesota 55125

United States

GI Alliance

Jackson, Mississippi 39232

United States

Gateway GI Research (Objective Health)

St Louis, Missouri 63141

United States

Las Vegas Medical Research LLC, DBA Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Northwell Health North Sore University Hospital

Manhasset, New York 11030

United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York 10032

United States

UNC Chapel Hill

Chapel Hill, North Carolina 27599

United States

Great Lakes Gastro

Mentor, Ohio 44060

United States

Pennsylvania Hospital

Philadelphia, Pennsylvania 19107

United States

Columbia Digestive Health Research (Objective Health)

Columbia, South Carolina 29204

United States

Sanford Health

Sioux Falls, South Dakota 57105

United States

Amarillo Premier Research (Objective Health)

Amarillo, Texas 79106

United States

Digestive Research of Central Texas (Objective Health)

Waco, Texas 76712

United States

Digestive Health Research of North Texas (Objective Health)

Wichita Falls, Texas 76301

United States