BOOM-IBD2 Pivotal Trial-Prospective, single-arm, multi-center, international clinical trial of sacral neuromodulation (SNM) in subjects with IBD
BOOM-IBD2: A study of sacral neuromodulation (SNM) for the treatment of Inflammatory Bowel Disease (IBD)
Sponsor: Boomerang Medical
Enrolling: Male and Female Patients
Study Length: 52 Weeks
Clinic Visits: 10
IRB Number: AAAV4351
U.S. Govt. ID: NCT06571669
Contact: Claudia Musat, Research Manager: 212-342-4102 / cm2065@cumc.columbia.edu
Additional Study Information: If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and approved by the FDA to treat overactive bladder and fecal incontinence, its use in this study for the treatment of UC is investigational. If you decide to participate in this study, you will be one of up to 25 subjects at Columbia University Irving Medical Center (CUIMC). Your participation in this study will be approximately 1 year long.
Investigator
Marco Bertucci Zoccali, MD
Do You Qualify?
1.Have you been diagnosed with Ulcerative Colitis more than 3 months ago? Yes No
2.Do you experience urgency a few days a week? Yes No
3.Have not tried more than 3 biologic medications in the past? Yes No
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For more information, please contact:
Claudia Musat, Research Manager
cm2065@cumc.columbia.edu
212-342-4102
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