BOOM-IBD2 Pivotal Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBoomerang Medical
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Neuromodulation
DeviceNeuromodulation
Treatment groups
137 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bowel Urgency
Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov