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RECRUITING
NCT06915337
NA

Magnet Anastomosis in Patients Undergoing Gastric Surgery

Sponsor: GI Windows, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.

Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-03-29

Completion Date

2026-06

Last Updated

2026-02-13

Healthy Volunteers

No

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.

Locations (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, Chile

Mohak Hitech Specialty Hospital

Indore, Madhya Pradesh, India