Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Neuromodulation

Treatment groups

137 Participants
are divided into 1 treatment group

Locations

19
California
Gastroenterology Medical Clinic (Objective Health)95630, Folsom United States
Center for Colorectal Innovation90048, Los Angeles United States
Hoag Hospital92663, Newport Beach United States
PAMF (Palo Alto Medical Foundation)94301, Palo Alto United States

Sponsors and collaborators

Boomerang Medical

Lead sponsor

Source ClinicalTrials.gov