NCT07276529

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (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 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.

Detailed description

This is a prospective, single-center, single-arm, early feasibility clinical study. Patients who are scheduled for laparoscopic colon surgery requiring an anastomosis will be evaluated for participation in the study. Study Cohorts: * Roll-In (Training) Cohort: A roll-in phase will be included for centers that do not have previous experience with the SFM device. A maximum of 3 roll-in participants will be enrolled. Data from roll-in participants will be summarized separately from the Primary Analysis Cohort. * Primary Analysis Cohort: A minimum of 17 participants undergoing side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc. Patients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Flexagon SFM System plus OTOLoc and procedures will be performed under general anesthesia. Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.

Conditions

• Colorectal Cancer
• Diverticular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-12-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study