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BOOM-IBD2 Pivotal Clinical Trial
Sponsor: 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.
Official title: BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
137
Start Date
2025-01-31
Completion Date
2027-11-30
Last Updated
2026-05-13
Healthy Volunteers
No
Interventions
Neuromodulation
Neuromodulation
Locations (19)
Gastroenterology Medical Clinic (Objective Health)
Folsom, California, United States
Center for Colorectal Innovation
Los Angeles, California, United States
Hoag Hospital
Newport Beach, California, United States
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, United States
Kansas Gastro
Wichita, Kansas, United States
MN Urology
Woodbury, Minnesota, United States
GI Alliance
Jackson, Mississippi, United States
Gateway GI Research (Objective Health)
St Louis, Missouri, United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, United States
Northwell Health North Sore University Hospital
Manhasset, New York, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Great Lakes Gastro
Mentor, Ohio, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Columbia Digestive Health Research (Objective Health)
Columbia, South Carolina, United States
Sanford Health
Sioux Falls, South Dakota, United States
Amarillo Premier Research (Objective Health)
Amarillo, Texas, United States
Digestive Research of Central Texas (Objective Health)
Waco, Texas, United States
Digestive Health Research of North Texas (Objective Health)
Wichita Falls, Texas, United States