BOOM-IBD2 Pivotal Clinical Trial

Boomerang Medical

Status: Enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Device: Neuromodulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571669

BOOM-IBD2 (CIP-B02)

Details and patient eligibility

About

Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.

Full description

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.

Enrollment: 137 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Patients implanted with neuromodulation

Treatment:

Device: Neuromodulation