What is the purpose of this study?
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.
Eligibility
- 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
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
- Disease Type/ConditionUlcerative Colitis, Inflammatory Bowel Diseases
- Principal InvestigatorCaroline Hwang, MD
- Co-InvestigatorsRashmi Kumar, MD, Monica McCawley, NP
- Age GroupAdult, Older Adult
- PhaseN/A
- ClinicalTrials.gov IDNCT06571669
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
Stay up-to-date on the latest news from Hoag
By submitting this request, you agree to receive communications from Hoag and accept our Privacy Policy and Terms of Use.