BOOM-IBD2 Pivotal Neuromodulation for Ulcerative Colitis
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
NA · Boomerang Medical · NCT06571669
This study tries a small device placed under the skin that sends mild signals to a nerve near the tailbone to reduce bowel urgency in adults with ulcerative colitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 137 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Boomerang Medical (industry) |
| Locations | 19 sites (Folsom, California and 18 other locations) |
| Trial ID | NCT06571669 on ClinicalTrials.gov |
What this trial studies
The trial implants a small neuromodulation device under the skin near the tailbone during a same-day procedure to deliver mild electrical signals to a nearby nerve. All enrolled adults (ages 18–85) with ulcerative colitis receive the device; there is no placebo or sham group. The primary outcome is change in bowel urgency at 12 weeks measured with a standard urgency rating scale, and participants are followed with visits for 12 months. The approach aims to alter neural signaling to improve urgency and related bowel symptoms.
Who should consider this trial
Good fit: Adults aged 18–85 with a diagnosis of ulcerative colitis who experience bothersome bowel urgency and can consent and attend follow-up visits are the ideal candidates.
Not a fit: People with active colonic infections (such as C. difficile or CMV), colonic perforation, fulminant colitis requiring emergency surgery, certain other colitis types, unresected colonic neoplasia, strictures preventing colonoscopy, significant comorbid medical or psychiatric conditions, or other listed exclusions are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the device could reduce bowel urgency and improve daily function and quality of life for people with ulcerative colitis.
How similar studies have performed: Related nerve-stimulation approaches like sacral neuromodulation have shown benefits for some bowel disorders, but this specific subcutaneous tailbone-directed device is relatively new and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Folsom, California and 18 other locations
- Gastroenterology Medical Clinic (Objective Health) — Folsom, California, United States (RECRUITING)
- Center for Colorectal Innovation — Los Angeles, California, United States (RECRUITING)
- Hoag Hospital — Newport Beach, California, United States (RECRUITING)
- PAMF (Palo Alto Medical Foundation) — Palo Alto, California, United States (RECRUITING)
- Kansas Gastro — Wichita, Kansas, United States (RECRUITING)
- MN Urology — Woodbury, Minnesota, United States (RECRUITING)
- GI Alliance — Jackson, Mississippi, United States (RECRUITING)
- Gateway GI Research (Objective Health) — St Louis, Missouri, United States (RECRUITING)
- Las Vegas Medical Research LLC, DBA Vector Clinical Trials — Las Vegas, Nevada, United States (RECRUITING)
- Northwell Health North Sore University Hospital — Manhasset, New York, United States (NOT_YET_RECRUITING)
- Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (RECRUITING)
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
- Great Lakes Gastro — Mentor, Ohio, United States (RECRUITING)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
- Columbia Digestive Health Research (Objective Health) — Columbia, South Carolina, United States (RECRUITING)
- Sanford Health — Sioux Falls, South Dakota, United States (RECRUITING)
- Amarillo Premier Research (Objective Health) — Amarillo, Texas, United States (RECRUITING)
- Digestive Research of Central Texas (Objective Health) — Waco, Texas, United States (RECRUITING)
- Digestive Health Research of North Texas (Objective Health) — Wichita Falls, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Deborah Reasner
- Email: deb@boomerangmedical.com
- Phone: 210-722-6192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases