BOOMERANG IBD-I CLINICAL TRIAL
Boomerang: Study of InterStim Neurostimulator (InterStim) for Patients with Crohns Disease (CD) or Ulcerative Colitis
Sponsor: Boomerang Medical, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU2455
U.S. Govt. ID: NCT05414955
Contact: Shivani Guha: / sg4365@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate the safety and performance of sacral nerve stimulation (SNS) using an FDA-approved device called InterStim Neurostimulator (InterStim) in study participants with active Crohn's disease (CD) or ulcerative colitis. The goal of the study team is to reduce inflammation and symptoms associated with these conditions. This research is a limited clinical investigation study with an approved device in an experimental clinical use. While this device has been studied and approved by the FDA to treat overactive bladder and fecal incontinence, participants of this study will be among the first involved in clinical research for the use of the device in the treatment of Crohn's disease and ulcerative colitis. Most recently, the SNS device has been used in pre-clinical research studies with individuals suffering from CD & UC and has shown promising benefits. If you decide to participate in this study, you will be one of up to 10 subjects at Columbia University Irving Medical Center (CUIMC)/ The New York Presbyterian Hospital (NYPH). This study will be approximately 3 years long, including follow-up procedure.
Investigator
Marco Bertucci Zoccali, MD
Do You Qualify?
Are you between the ages of 18-75? Yes No
Have you been diagnosed with Crohn's disease or ulcerative colitis? Yes No
Are you able to comply with the protocol and all follow-up requirements? Yes No
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You may be eligible for this study

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For more information, please contact:
Shivani Guha
sg4365@cumc.columbia.edu