Status:
RECRUITING
BOOM-IBD2 Pivotal Clinical Trial
Lead Sponsor:
Boomerang Medical
Conditions:
Ulcerative Colitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06571669
Start Date
January 31 2025
End Date
October 1 2026
Last Update
July 3 2025
Active Locations (10)
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1
Center for Colorectal Innovation
Los Angeles, California, United States, 90048
2
Hoag Hospital
Newport Beach, California, United States, 92663
3
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, United States, 94301
4
Kansas Gastro
Wichita, Kansas, United States, 67226-8119