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 BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.
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: 2026-10
Last updated: 2025-07-03
Interventions
Device: Neuromodulation
Primary outcomes
- • Bowel Urgency (12 weeks)
Sponsor
Boomerang Medical · industry
Contacts & investigators
ContactMalea D'Amico · contact · mdamico@boomerangmedical.com · 844-423-9747
ContactColleen Holthe · contact · colleen@boomerangmedical.com · 844-423-9747
All locations (10)
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
Objective Health - St. LouisRecruiting
St Louis, Missouri, United States
Las Vegas Medical Research LLC, DBA Vector Clinical TrialsRecruiting
Las Vegas, Nevada, 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
Objective Health - AmarilloRecruiting
Amarillo, Texas, United States
Objective Health - Central TexasRecruiting
Waco, Texas, United States