BOOM-IBD2 Pivotal Clinical Trial
Start Date
1/31/2025
Completion Date
11/30/2027
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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Neuromodulation
Conditions
Locations
Gastroenterology Medical Clinic (Objective Health)
Folsom, California 95630
United States
Center for Colorectal Innovation
Los Angeles, California 90048
United States
Hoag Hospital
Newport Beach, California 92663
United States
PAMF (Palo Alto Medical Foundation)
Palo Alto, California 94301
United States
Kansas Gastro
Wichita, Kansas 67226-8119
United States
MN Urology
Woodbury, Minnesota 55125
United States
GI Alliance
Jackson, Mississippi 39232
United States
Gateway GI Research (Objective Health)
St Louis, Missouri 63141
United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada 89128
United States
Northwell Health North Sore University Hospital
Manhasset, New York 11030
United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York 10032
United States
UNC Chapel Hill
Chapel Hill, North Carolina 27599
United States
Great Lakes Gastro
Mentor, Ohio 44060
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
United States
Columbia Digestive Health Research (Objective Health)
Columbia, South Carolina 29204
United States
Sanford Health
Sioux Falls, South Dakota 57105
United States
Amarillo Premier Research (Objective Health)
Amarillo, Texas 79106
United States
Digestive Research of Central Texas (Objective Health)
Waco, Texas 76712
United States
Digestive Health Research of North Texas (Objective Health)
Wichita Falls, Texas 76301
United States