BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Gastroenterology Medical Clinic (Objective Health)
RECRUITING
Folsom
Center for Colorectal Innovation
RECRUITING
Los Angeles
Hoag Hospital
RECRUITING
Newport Beach
PAMF (Palo Alto Medical Foundation)
RECRUITING
Palo Alto
Kansas
Kansas Gastro
RECRUITING
Wichita
Minnesota
MN Urology
RECRUITING
Woodbury
Missouri
Gateway GI Research (Objective Health)
RECRUITING
St Louis
Mississippi
GI Alliance
RECRUITING
Jackson
North Carolina
UNC Chapel Hill
RECRUITING
Chapel Hill
Nevada
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
RECRUITING
Las Vegas
New York
Northwell Health North Sore University Hospital
NOT_YET_RECRUITING
Manhasset
Columbia University Irving Medical Center/New York Presbyterian Hospital
RECRUITING
New York
Ohio
Great Lakes Gastro
RECRUITING
Mentor
Pennsylvania
Pennsylvania Hospital
NOT_YET_RECRUITING
Philadelphia
South Carolina
Columbia Digestive Health Research (Objective Health)
RECRUITING
Columbia
South Dakota
Sanford Health
RECRUITING
Sioux Falls
Texas
Amarillo Premier Research (Objective Health)
RECRUITING
Amarillo
Digestive Research of Central Texas (Objective Health)
RECRUITING
Waco
Digestive Health Research of North Texas (Objective Health)
RECRUITING
Wichita Falls
Contact Information
Primary
Deborah Reasner
deb@boomerangmedical.com
210-722-6192
Backup
Bruce Van Deman
bruce@boomerangmedical.com
949-413-1301
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 137
Treatments
Experimental: Treatment Arm
Patients implanted with neuromodulation
Related Therapeutic Areas
Sponsors
Leads: Boomerang Medical