BOOM-IBD2 Pivotal Clinical Trial

Launched by BOOMERANG MEDICAL · Aug 23, 2024

Keywords

ClinConnect Summary

The BOOM-IBD2 clinical trial is looking at a new treatment option for people with ulcerative colitis, a type of inflammatory bowel disease (IBD). This trial will test a procedure called sacral neuromodulation, which involves using a small device to help manage symptoms of ulcerative colitis. The trial is not yet recruiting participants, but it aims to include adults aged 18 to 85 years who have been diagnosed with ulcerative colitis and are willing to follow the study guidelines.

To be eligible for this trial, participants should not have any serious medical conditions that could affect the study's results or the use of the device. They should also not have certain infections or previous surgeries related to ulcerative colitis. If someone decides to join the study, they can expect to work closely with the research team, sign an agreement to participate, and attend follow-up appointments to monitor their progress. Overall, this trial aims to find out if sacral neuromodulation can be an effective treatment for managing ulcerative colitis symptoms.

Gender

ALL

Eligibility criteria

• 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