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Recruiting Not applicable

BOOM-IBD2 Pivotal Clinical Trial

NCT06571669 · tracked via the Priya Life Science USA tracker
Sponsor
Boomerang Medical
Phase
Not applicable
Started
2025-01-31
Last updated
2026-08-06

Condition(s) studied

Ulcerative ColitisInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Neuromodulation

Neuromodulation: Neuromodulation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bowel Urgency — 12 weeks
    Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.

Trial sites (19)

FacilityCityRegionStatus
Gastroenterology Medical Clinic (Objective Health) Folsom California Recruiting
Center for Colorectal Innovation Los Angeles California Recruiting
Hoag Hospital Newport Beach California Recruiting
PAMF (Palo Alto Medical Foundation) Palo Alto California Recruiting
Kansas Gastro Wichita Kansas Recruiting
MN Urology Woodbury Minnesota Recruiting
GI Alliance Jackson Mississippi Recruiting
Gateway GI Research (Objective Health) St Louis Missouri Recruiting
Las Vegas Medical Research LLC, DBA Vector Clinical Trials Las Vegas Nevada Recruiting
Northwell Health North Shore University Hospital Manhasset New York Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York Recruiting
UNC Chapel Hill Chapel Hill North Carolina Recruiting
Great Lakes Gastro Mentor Ohio Withdrawn
Pennsylvania Hospital Philadelphia Pennsylvania Not Yet Recruiting
Columbia Digestive Health Research (Objective Health) Columbia South Carolina Recruiting
Sanford Health Sioux Falls South Dakota Recruiting
Amarillo Premier Research (Objective Health) Amarillo Texas Recruiting
Digestive Research of Central Texas (Objective Health) Waco Texas Recruiting
Digestive Health Research of North Texas (Objective Health) Wichita Falls Texas Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571669 on ClinicalTrials.gov ↗ ← All trials in the USA