56
Participants
Start Date
March 29, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
March 31, 2026
Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. 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