BOOM-IBD2 Pivotal Clinical Trial
Recruiting · NCT06571669 · Interventional (participants receive a specific treatment) · Lead sponsor: Boomerang Medical
View the official record on ClinicalTrials.gov →Interventions studied
Neuromodulation
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
19 locations listed across 13 US states.
- Gastroenterology Medical Clinic (Objective Health) - Folsom, California, United States
- Center for Colorectal Innovation - Los Angeles, California, United States
- Hoag Hospital - Newport Beach, California, United States
- PAMF (Palo Alto Medical Foundation) - Palo Alto, California, United States
- Kansas Gastro - Wichita, Kansas, United States
- MN Urology - Woodbury, Minnesota, United States
- GI Alliance - Jackson, Mississippi, United States
- Gateway GI Research (Objective Health) - St Louis, Missouri, United States
- Las Vegas Medical Research LLC, DBA Vector Clinical Trials - Las Vegas, Nevada, United States
- Northwell Health North Shore University Hospital - Manhasset, New York, United States
- Columbia University Irving Medical Center/New York Presbyterian Hospital - New York, New York, United States
- UNC Chapel Hill - Chapel Hill, North Carolina, United States
- Great Lakes Gastro - Mentor, Ohio, United States
- Pennsylvania Hospital - Philadelphia, Pennsylvania, United States
- Columbia Digestive Health Research (Objective Health) - Columbia, South Carolina, United States
- Sanford Health - Sioux Falls, South Dakota, United States
- Amarillo Premier Research (Objective Health) - Amarillo, Texas, United States
- Digestive Research of Central Texas (Objective Health) - Waco, Texas, United States
- Digestive Health Research of North Texas (Objective Health) - Wichita Falls, Texas, United States