Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

NARecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 29, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Colon Anastomosis
Interventions
DEVICE

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.

Trial Locations (1)

454555

RECRUITING

Mohak Hitech Specialty Hospital, Indore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GI Windows, Inc.

INDUSTRY

NCT06915818 - Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery | Biotech Hunter | Biotech Hunter