Actively Recruiting
BOOM-IBD2 Pivotal Clinical Trial
Led by Boomerang Medical · Updated on 2026-05-13
137
Participants Needed
19
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BOOM-IBD2 Pivotal Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18 to 85 years
- Diagnosed with ulcerative colitis
- Able and willing to provide informed consent
- Able and willing to comply with study protocol and follow-up requirements
You will not qualify if you...
- Significant medical conditions interfering with study or device function
- Psychiatric or personality disorders as determined by investigator
- Active bacterial infections with risk of bacteremia or sepsis
- Active Clostridium difficile infection in the colon
- Active cytomegalovirus infection in the colon
- Evidence of colonic perforation
- Fulminant colitis needing emergency surgery
- Microscopic, ischemic, or infectious colitis
- Unresected colon neoplasia
- Colonic stricture blocking colonoscope passage
- Current gastrointestinal cancer
- Participation in another clinical trial
- Previous ulcerative colitis surgery or likely need for it
- Prior neurostimulation device implantation or trial participation
- Unable to operate the patient programmer device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Gastroenterology Medical Clinic (Objective Health)
Folsom, California, United States, 95630
Actively Recruiting
2
Center for Colorectal Innovation
Los Angeles, California, United States, 90048
Actively Recruiting
3
Hoag Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
4
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, United States, 94301
Actively Recruiting
5
Kansas Gastro
Wichita, Kansas, United States, 67226-8119
Actively Recruiting
6
MN Urology
Woodbury, Minnesota, United States, 55125
Actively Recruiting
7
GI Alliance
Jackson, Mississippi, United States, 39232
Actively Recruiting
8
Gateway GI Research (Objective Health)
St Louis, Missouri, United States, 63141
Actively Recruiting
9
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, United States, 89128
Actively Recruiting
10
Northwell Health North Sore University Hospital
Manhasset, New York, United States, 11030
Not Yet Recruiting
11
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
12
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
13
Great Lakes Gastro
Mentor, Ohio, United States, 44060
Actively Recruiting
14
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
15
Columbia Digestive Health Research (Objective Health)
Columbia, South Carolina, United States, 29204
Actively Recruiting
16
Sanford Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
17
Amarillo Premier Research (Objective Health)
Amarillo, Texas, United States, 79106
Actively Recruiting
18
Digestive Research of Central Texas (Objective Health)
Waco, Texas, United States, 76712
Actively Recruiting
19
Digestive Health Research of North Texas (Objective Health)
Wichita Falls, Texas, United States, 76301
Actively Recruiting
Research Team
D
Deborah Reasner
CONTACT
B
Bruce Van Deman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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