BOOM-IBD2 Pivotal Clinical Trial

Boomerang Medical

Status

Not yet enrolling

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Treatments

Device: Neuromodulation

Study type

Interventional

Funder types

Industry

Identifiers

BOOM-IBD2 (CIP-B02)

Details and patient eligibility

About

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.

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