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BOOM-IBD2 Pivotal Clinical Trial

RecruitingNA

Sponsor: Boomerang Medical

Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases

Interventions: Neuromodulation

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (19)

Folsom, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palo Alto, California, United States
Wichita, Kansas, United States
Woodbury, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Manhasset, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Mentor, Ohio, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Sioux Falls, South Dakota, United States
Amarillo, Texas, United States
Waco, Texas, United States
Wichita Falls, Texas, United States