BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Boomerang Medical
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.
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- 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 bacteremi…
Interventions
- DeviceNeuromodulation
Neuromodulation
Locations (19)
- Gastroenterology Medical Clinic (Objective Health)Folsom, California
- Center for Colorectal InnovationLos Angeles, California
- Hoag HospitalNewport Beach, California
- PAMF (Palo Alto Medical Foundation)Palo Alto, California
- Kansas GastroWichita, Kansas
- MN UrologyWoodbury, Minnesota