56
Participants
Start Date
March 29, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
March 31, 2026
Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. 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 lumens until the anastomosis is fully formed.
RECRUITING
Mohak Hitech Specialty Hospital, Indore
Lead Sponsor
GI Windows, Inc.
INDUSTRY