Ulcerative coliits is an inflammatory bowel disease that affects the colon. Standard treatments include steroids, immune modulators and advanced therapies. In severe cases, surgery may be needed.
The BOOM-IBD2 Clinical Trial is evaluating sacral nerve stimulation to treat ulcerative colitis using a small implantable medical device. The device uses gentle electrical impulses to activate a nerve pathway in order to reduce inflammation and improve IBD symptoms, and has been granted Breakthrough Device Designation by the FDA for the treatment of ulcerative colitis.
Sacral nerve stimulation is already FDA approved for fecal incontience and urinary incontinence in the United States. The purpose of the current clinical trial in ulcerative colitis is to expand the use of this treatment for patients with ulcerative colitis.
Participation is completely voluntary with no additional cost to you.
If you are selected to participate in the study, the procedure to implant your device will be performed as a same-day outpatient procedure, and does not involve an overnight hospital stay. The nerve stimulator will be placed under the skin, so nothing will show outside your body.
There are additional trial requirements to participate. Our team will help determine if you are a candidate.
To see if you qualify please call us at the Center for Colorectal Innovation in Beverly Hills, Los Angeles, CA at 310-289-9224 or email Gayane at gayane.ovsepyan@cshs.org. Dr. Karen Zaghiyan and her clinical and research team look forward to your participation and enrollment. More information can also be found on the Boom-IBD2 website.
