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RECRUITING
NCT07276529
NA

Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

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 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.

Official title: Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-02

Completion Date

2026-08

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DEVICE

Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses

The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection

Locations (1)

Orlando Health

Orlando, Florida, United States