70
Participants
Start Date
October 4, 2024
Primary Completion Date
June 30, 2025
Study Completion Date
August 31, 2025
Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
This study will investigate one type of intervention: small bowel anastomosis creation in subjects undergoing laparoscopic small bowel surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically into two different sections of small bowel that are intended to be anastomosed. An OTOLoc device will be deployed into the small bowel wall in one section of the small bowel to provide access for the deployment of a Flexagon SFM into that section of bowel. The process is repeated at the second section of bowel. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two sections of bowel until the anastomosis is fully formed.
Duke Regional Hospital, Durham
Orlando Health, Orlando
University of Miami, Coral Gables
Endeavor Health, Evanston
UT Health Houston, Houston
Seger Bariatrics and Metabolism, LLC, San Antonio
Fresno Community Hospital and Medical Center, Clovis
Lead Sponsor
GI Windows, Inc.
INDUSTRY