BOOM-IBD2 Pivotal Clinical Trial

Recruiting now · Not applicable

Conditions studied: Ulcerative Colitis, Inflammatory Bowel Diseases

In brief

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.

Key facts

Study ID

NCT06571669

Run by

Boomerang Medical

People needed

137

Starts

2025-01-31

Expected to finish

2027-11-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Gastroenterology Medical Clinic (Objective Health) — Folsom, California, United States (enrolling)
• Center for Colorectal Innovation — Los Angeles, California, United States (enrolling)
• Hoag Hospital — Newport Beach, California, United States (enrolling)
• PAMF (Palo Alto Medical Foundation) — Palo Alto, California, United States (enrolling)
• Kansas Gastro — Wichita, Kansas, United States (enrolling)
• MN Urology — Woodbury, Minnesota, United States (enrolling)
• GI Alliance — Jackson, Mississippi, United States (enrolling)
• Gateway GI Research (Objective Health) — St Louis, Missouri, United States (enrolling)
• Las Vegas Medical Research LLC, DBA Vector Clinical Trials — Las Vegas, Nevada, United States (enrolling)
• Northwell Health North Shore University Hospital — Manhasset, New York, United States (enrolling)
• Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (enrolling)
• UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Sanford Health — Sioux Falls, South Dakota, United States (enrolling)
• Amarillo Premier Research (Objective Health) — Amarillo, Texas, United States (enrolling)
• Digestive Research of Central Texas (Objective Health) — Waco, Texas, United States (enrolling)
• Columbia Digestive Health Research (Objective Health) — Columbia, South Carolina, United States (enrolling)
• Great Lakes Gastro — Mentor, Ohio, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Digestive Health Research of North Texas (Objective Health) — Wichita Falls, Texas, United States

Full record on ClinicalTrials.gov

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