Device to Help Bowel Urgency in Ulcerative Colitis
BOOM-IBD2 Pivotal Clinical Trial
Recruiting
N/AInterventional Study
Ulcerative ColitisInflammatory Bowel Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
137 (estimated)
Sponsor
Boomerang Medical · Industry
Who this trial is looking for
This trial is looking for people between 18 and 85 years old who have ulcerative colitis. Participants will undergo a quick procedure to have a small device placed under their skin that may help reduce bowel urgency.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I have been diagnosed with ulcerative colitis.
I can provide consent to participate.
I am willing to follow the study requirements.
You may not be able to join if
I have a significant medical condition that might interfere with the study.
I have a psychiatric or personality disorder.
I have an active bacterial infection.
I have an active clostridium difficile infection.
I have current cancer in my gastrointestinal tract.
I have had surgery for ulcerative colitis before.
I am currently in another clinical trial.
I have trouble using the required device.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
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 Criter…
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
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