RecruitingNot ApplicableNCT07351071

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)


Sponsor

Medtronic - MITG

Enrollment

137 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a surgical stapling device called the Signia circular stapler, used to reconnect the bowel after colon or rectal surgery. Researchers want to track how well the device works and how patients recover after these types of colorectal operations. **You may be eligible if:** - You are 18 years or older - You are scheduled for a planned (non-emergency) colon, sigmoid, or rectal surgery that requires reconnecting the bowel - Your surgeon plans to use the Signia circular stapler for your procedure - You are willing and able to follow the study's schedule and requirements **You may NOT be eligible if:** - Your surgery is an emergency or is being done again for the same problem - You are pregnant - You have a serious medical condition or a life expectancy of less than 6 months - You have a bleeding disorder or are on blood thinners that haven't been reversed - You have had chemotherapy or biologic therapy within the last 6 weeks - You have been on steroids or immune-suppressing drugs for more than 3 months in the past year - You are also having another section of your colon removed at the same time - You are currently in another research study that could affect the results 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

DEVICESignia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

Signia™ Circular Stapling system used for the creation of an anastomosis


Locations(8)

Yale University

New Haven, Connecticut, United States

The University of South Florida

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

SSM Health St. Mary's Hospital - Madison

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07351071


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