Magnet Anastomosis in Patients Undergoing Gastric Surgery

NARecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 29, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Gastric Anastomosis (Site)
Interventions
DEVICE

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.

Trial Locations (1)

454555

RECRUITING

Mohak Hitech Specialty Hospital, Indore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GI Windows, Inc.

INDUSTRY