RecruitingNot ApplicableNCT07276529

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


Sponsor

GI Windows, Inc.

Enrollment

20 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety of a new surgical technique that uses magnetic devices (SFM and OTOLoc) to create a connection between parts of the colon or rectum during bowel surgery, which may reduce complications compared to traditional methods. **You may be eligible if...** - You are 22 or older - You are scheduled for colon or rectal surgery (right or left hemicolectomy, sigmoidectomy, or low anterior resection) - You have been medically cleared for surgery - If you have cancer, you completed chemotherapy at least 2 months ago - You live within 150 miles of the study center and can return for follow-up visits - You are willing to stop smoking during the study **You may NOT be eligible if...** - You are allergic to silicone, nickel, titanium, or Nitinol - Your BMI is over 55 - You have a severe bowel abnormality or history of repeated bowel blockages - You have uncontrolled diabetes, severe kidney disease, or serious heart conditions - You have a weakened immune system or are on high-dose steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFlexagon 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

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NCT07276529


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