BOOMERANG IBD-I CLINICAL TRIAL
Sponsor: |
Boomerang Medical, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU2455 |
U.S. Govt. ID: |
NCT05414955 |
Contact: |
Shivani Guha: / sg4365@cumc.columbia.edu |
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 moderate to severe 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 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 20 subjects at Columbia University Irving Medical Center (CUIMC)/ The New York Presbyterian Hospital (NYPH). This study will be approximately 1 year long, including follow-up procedure.
This study is closed
Investigator
Marco Bertucci Zoccali, MD
Are you between the ages of 18-75? |
Yes |
No |
Have you been diagnosed with ulcerative colitis? |
Yes |
No |
Are you able to comply with the protocol and all follow-up requirements? |
Yes |
No |