RecruitingNot ApplicableNCT06571669
BOOM-IBD2 Pivotal Clinical Trial
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
Sponsor
Boomerang Medical
Enrollment
137 participants
Start Date
Jan 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Plain Language Summary
Simplified for easier understanding
This pivotal clinical trial tests an investigational device or treatment (BOOM) for ulcerative colitis (UC) — a chronic inflammatory bowel disease that causes ongoing inflammation and ulcers in the lining of the large intestine, leading to diarrhea, pain, and bleeding. The study aims to confirm that the BOOM intervention is safe and effective.
**You may be eligible if:**
- You are between 18 and 85 years old
- You have a confirmed diagnosis of ulcerative colitis
- You are able and willing to consent and attend all follow-up visits
**You may NOT be eligible if:**
- You have a serious medical condition that may interfere with the study or confound results
- You have an active bacterial infection posing a risk of sepsis (e.g., abscess)
- You have active C. difficile or cytomegalovirus (CMV) infection in the colon
- You have evidence of a hole in the colon (perforation) or need emergency surgery
- You have a colonic tumor that has not been removed
- You have a psychiatric or personality disorder at the investigator's discretion
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICENeuromodulation
Neuromodulation
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06571669
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