BOOM-IBD2 Pivotal Clinical Trial
Purpose
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
- Ulcerative Colitis
- Inflammatory Bowel Diseases
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study - Any psychiatric or personality disorder at the discretion of the study investigator - Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) - Active clostridium difficile infection of the colon - Active cytomegalovirus (CMV) infection of the colon - Evidence of colonic perforation - Fulminant colitis requiring emergency surgery - Microscopic, ischemic or infectious colitis - Unresected neoplasia of the colon - Colonic stricture unable to pass a colonoscope - Current evidence of cancer in the gastrointestinal tract - Current participation in another clinical trial - Previous history of surgery for ulcerative colitis, or probably to require such intervention - Previously implanted with a neurostimulation device or participated in a neurostimulation trial - Inability to operate the patient programmer
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Patients implanted with neuromodulation |
|
Recruiting Locations
Gastroenterology Medical Clinic (Objective Health)
Folsom, California 95630
Folsom, California 95630
Center for Colorectal Innovation
Los Angeles, California 90048
Los Angeles, California 90048
Hoag Hospital
Newport Beach, California 92663
Newport Beach, California 92663
PAMF (Palo Alto Medical Foundation)
Palo Alto, California 94301
Palo Alto, California 94301
Kansas Gastro
Wichita, Kansas 67226-8119
Wichita, Kansas 67226-8119
MN Urology
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
GI Alliance
Jackson, Mississippi 39232
Jackson, Mississippi 39232
Gateway GI Research (Objective Health)
St Louis, Missouri 63141
St Louis, Missouri 63141
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Northwell Health North Shore University Hospital
Manhasset, New York 11030
Manhasset, New York 11030
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York 10032
New York, New York 10032
UNC Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Columbia Digestive Health Research (Objective Health)
Columbia, South Carolina 29204
Columbia, South Carolina 29204
Sanford Health
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
Amarillo Premier Research (Objective Health)
Amarillo, Texas 79106
Amarillo, Texas 79106
Digestive Research of Central Texas (Objective Health)
Waco, Texas 76712
Waco, Texas 76712
More Details
- Status
- Recruiting
- Sponsor
- Boomerang Medical
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.