BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 137
- Locations
- 19
- Primary Endpoint
- Bowel Urgency
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Arm
Patients implanted with neuromodulation
Intervention: Neuromodulation (Device)
Outcomes
Primary Outcomes
Bowel Urgency
Time Frame: 12 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.
Secondary Outcomes
No secondary outcomes reported