ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Bowel urgency is a common, distressing symptom in ulcerative colitis; a minimally invasive implant that reduces urgency could improve daily functioning and quality of life if proven effective and safe.
Who Should Pay Attention
Adults with ulcerative colitis experiencing significant bowel urgency, gastroenterologists and colorectal specialists, and researchers interested in neuromodulation for IBD symptoms.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment137 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
The BOOM-IBD2 study is an interventional, non-randomized trial where all participants receive the implant; there is no placebo or sham control. The primary outcome is change in bowel urgency at 12 weeks measured by a patient-reported numeric rating scale (URNS).
Enrollment is planned for up to 137 adults (18–85) with ulcerative colitis, and study visits continue for 12 months. The device is placed during a same-day procedure and intended to modulate a sacral/tailbone-area nerve to relieve urgency symptoms.
The trial excludes people with active infections of the colon, unresected colonic neoplasia, prior neurostimulation implants, recent colectomy, or other conditions that could confound results.
If you’re considering participation, discuss with your gastroenterologist whether an implantable neuromodulation device and a single-arm study design are appropriate for your situation.
Keep In Mind
This is a recruiting interventional trial registered on ClinicalTrials.gov. The study is single-arm (no placebo/sham), so interpretation of efficacy will depend on trial design details and comparative data. ClinicalTrials.gov entries describe planned procedures and outcomes but do not report results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorBoomerang Medical
Trial IDNCT06571669
Study typeInterventional
Trial phaseNA
Enrollment137 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 6, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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