NCT06571669Recruiting
BOOM-IBD2 Pivotal Clinical Trial
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 137 (estimated)
- First submitted
- 23 Aug 2024
- Start date
- 31 Jan 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Boomerang Medical
- Diseases
- Ulcerative colitis
- NCT number
- NCT06571669
What you commit to
- Study type: Interventional
- Planned participants: 137
- From 31 Jan 2025 to the primary completion date, 28 Feb 2027
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Fulminant colitis requiring emergency surgery
- 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
Other illness
- 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
- Current evidence of cancer in the gastrointestinal tract
Other
- Microscopic, ischemic or infectious colitis
- Unresected neoplasia of the colon
- Colonic stricture unable to pass a colonoscope
- Current participation in another clinical trial
- Inability to operate the patient programmer
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amarillo Premier Research (Objective Health) Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| UNC- Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Columbia Digestive Health Research (Objective Health) Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Gastroenterology Medical Clinic (Objective Health) Coordinator of this site? Confirm its status | Folsom | United States | Recruiting |
| GI Alliance Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Las Vegas Medical Research LLC, DBA Vector Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Center for Colorectal Innovation Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Northwell Health North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Great Lakes Gastro Coordinator of this site? Confirm its status | Mentor | United States | Withdrawn |
| Hoag Hospital Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| PAMF (Palo Alto Medical Foundation) Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Sanford Health Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Gateway GI Research (Objective Health) Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Digestive Research of Central Texas (Objective Health) Coordinator of this site? Confirm its status | Waco | United States | Recruiting |
| Kansas Gastro Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| Digestive Health Research of North Texas (Objective Health) Coordinator of this site? Confirm its status | Wichita Falls | United States | Active, not recruiting |
| MN Urology Coordinator of this site? Confirm its status | Woodbury | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.