Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
137 participants
INTERVENTIONAL
2025-01-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Patients implanted with neuromodulation
Neuromodulation
Neuromodulation
Interventions
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Neuromodulation
Neuromodulation
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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Boomerang Medical
INDUSTRY
Responsible Party
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Locations
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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
Objective Health - St. Louis
St Louis, Missouri, United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, 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
Objective Health - Amarillo
Amarillo, Texas, United States
Objective Health - Central Texas
Waco, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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BOOM-IBD2 (CIP-B02)
Identifier Type: -
Identifier Source: org_study_id
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