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Recruiting

BOOM-IBD2 Pivotal Clinical Trial

NCT06571669 · Boomerang Medical
In plain English

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Official title
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
About this study
The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.
Eligibility 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
Study design
Enrollment target: 137 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-31
Estimated completion: 2027-11-30
Last updated: 2026-05-13
Interventions
Device: Neuromodulation
Primary outcomes
  • Bowel Urgency (12 weeks)
Sponsor
Boomerang Medical · industry
Contacts & investigators
ContactDeborah Reasner · contact · deb@boomerangmedical.com · 210-722-6192
ContactBruce Van Deman · contact · bruce@boomerangmedical.com · 949-413-1301
All locations (19)
Gastroenterology Medical Clinic (Objective Health)Recruiting
Folsom, California, United States
Center for Colorectal InnovationRecruiting
Los Angeles, California, United States
Hoag HospitalRecruiting
Newport Beach, California, United States
PAMF (Palo Alto Medical Foundation)Recruiting
Palo Alto, California, United States
Kansas GastroRecruiting
Wichita, Kansas, United States
MN UrologyRecruiting
Woodbury, Minnesota, United States
GI AllianceRecruiting
Jackson, Mississippi, United States
Gateway GI Research (Objective Health)Recruiting
St Louis, Missouri, United States
Las Vegas Medical Research LLC, DBA Vector Clinical TrialsRecruiting
Las Vegas, Nevada, United States
Northwell Health North Sore University HospitalNot Yet Recruiting
Manhasset, New York, United States
Columbia University Irving Medical Center/New York Presbyterian HospitalRecruiting
New York, New York, United States
UNC Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Great Lakes GastroRecruiting
Mentor, Ohio, United States
Pennsylvania HospitalNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Columbia Digestive Health Research (Objective Health)Recruiting
Columbia, South Carolina, United States
Sanford HealthRecruiting
Sioux Falls, South Dakota, United States
Amarillo Premier Research (Objective Health)Recruiting
Amarillo, Texas, United States
Digestive Research of Central Texas (Objective Health)Recruiting
Waco, Texas, United States
Digestive Health Research of North Texas (Objective Health)Recruiting
Wichita Falls, Texas, United States
BOOM-IBD2 Pivotal Clinical Trial · TrialPath