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

Postoperative Complications Anastomotic Leaks Anastomotic Complication Colorectal Anastomosis Left-sided Colon Resection Anastomotic Leak Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases

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

Inclusion Criteria3

Subject is competent and willing to provide documented informed consent to participate in this clinical study
Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
Subject is ≥ 18 years of age at time of consent

Exclusion Criteria15

Subject is unable or unwilling to comply with the study requirements or follow-up schedule
Subject with ASA classification ≥ IV
Subject is pregnant (as determined by standard site practices)
The procedure is an emergency procedure
The procedure is a revision/reoperation for the same indication
The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
Subject will undergo multiple synchronous colon resections
Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
Any subject undergoing an ileal-anal pouch anastomosis surgery
Anastomosis not attempted with the Signia™ circular stapler
Any subject for which the device is intended to be used outside the instructions for use (IFU)