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BOOM-IBD2 Study for Ulcerative Colitis

This study, called BOOM-IBD2, is testing a neuromodulation device for people with ulcerative colitis (a long-lasting condition causing swelling and sores in the large intestine). The device is small and placed under your skin during a same-day procedure. It sends mild signals to a nerve near your tailbone. The main goal is to see if this device can help reduce bowel urgency after 12 weeks. Adults aged 18 to 85 who have been diagnosed with ulcerative colitis and are willing to follow study requirements may be able to join. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 137 participants. Everyone in the study will receive the neuromodulation device.
What's involved
You would have the neuromodulation device placed during a same-day procedure. Study visits will continue for 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring bowel urgency is at 12 weeks. Study visits continue for 12 months.

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NCT06571669

BOOM-IBD2 Pivotal Clinical Trial

Recruiting
NAAges 18–85InterventionalTreatment
Boomerang Medical
~137 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Neuromodulation

At a glance

Recruiting sites
16 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bowel Urgency
Measured over 12 weeks

Conditions

Ulcerative Colitis
Inflammatory Bowel Diseases

Explore related trials

Ulcerative Colitis

Where it's being run

19 sites across 13 states
California4
Texas3
New York2
Kansas1
Minnesota1
Mississippi1
Missouri1
Nevada1

Who to contact

Deborah Reasner
[email protected]
210-722-6192
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Bowel Urgency12 weeks

    Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.