NCT06915818

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Conditions

• Colon Anastomosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-29
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-04-08
• Last updated: 2026-02-13

Locations

2 sites across 2 countries: Chile, India

Regulatory

• FDA-regulated device study