| NCT ID | NCT06571669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boomerang Medical |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 137 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 137 participants in total. It began in 2025-01-31 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06571669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06571669 currently recruiting?
Yes, NCT06571669 is actively recruiting participants. Contact the research team at deb@boomerangmedical.com for enrollment information.
Where is the NCT06571669 trial being conducted?
This trial is being conducted at Folsom, United States, Los Angeles, United States, Newport Beach, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06571669 clinical trial?
NCT06571669 is sponsored by Boomerang Medical. The trial plans to enroll 137 participants.
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