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RECRUITING
NCT06915818
NA

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2025-03-29

Completion Date

2026-07

Last Updated

2026-02-13

Healthy Volunteers

No

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.

Locations (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, Chile

Mohak Hitech Specialty Hospital

Indore, Madhya Pradesh, India