UCRecruiting
BOOM-IBD2 Pivotal Clinical Trial
Not applicable · Testing Neuromodulation · 19 sites · Boomerang Medical
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Neuromodulation (a device) as a possible treatment. Condition(s) listed: Ulcerative Colitis and Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- Male or female
- 18 to 85 years of age
- Diagnosed with ulcerative colitis
Plus 2 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 137 participants are expected to take part.
- Start date: 2025-01-31.
- Main results expected around 2027-02-28 (estimate from the record).
- 19 study sites listed (16 marked recruiting) in United States.
Main thing being measured
- Bowel Urgency (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Inflammatory Bowel Diseases |
| Lead sponsor | Boomerang Medical |
| Enrollment | 137 (estimated) |
| Start date | 2025-01-31 |
| Primary completion (est.) | 2027-02-28 |
| First posted | 2024-08-26 |
| Last updated | 2026-08-06 |
| Official title | BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD. |
| ClinicalTrials.gov ID | NCT06571669 |
Interventions
- Neuromodulation (Device)
Neuromodulation
Full eligibility criteria (from the record)
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
Locations (19)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Shore University Hospital | Manhasset, New York | United States | 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 | Withdrawn |
| 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 | Active, not recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.