Back to Trials
NCT07351071NARecruiting

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

Medtronic - MITG

Start Date

12/30/2025

Completion Date

2/28/2027

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.

Detailed Description

The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections. The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.

Eligibility Criteria

Age Range: 18 years to No maximum

Preoperative Inclusion Criteria: 1. Subject is competent and willing to provide documented informed consent to participate in this clinical study 2. 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 3. Subject is ≥ 18 years of age at time of consent Preoperative Exclusion Criteria: 1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule 2. Subject with ASA classification ≥ IV 3. Subject is pregnant (as determined by standard site practices) 4. The procedure is an emergency procedure 5. The procedure is a revision/reoperation for the same indication 6. 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 7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study 8. Subject will undergo multiple synchronous colon resections 9. 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) 10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure 11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure) 12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure) 13. Any subject undergoing an ileal-anal pouch anastomosis surgery Intraoperative Exclusion Criteria 1. Anastomosis not attempted with the Signia™ circular stapler 2. Any subject for which the device is intended to be used outside the instructions for use (IFU)

Interventions

DEVICE

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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Colorectal AnastomosisLeft-sided Colon ResectionAnastomotic LeakAnastomotic ComplicationDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsAnastomotic Leaks

Locations

Yale University

New Haven, Connecticut 06520

United States

The University of South Florida

Tampa, Florida 33620

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Mayo Clinic

Rochester, Minnesota 55902

United States

Duke University

Durham, North Carolina 27705

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania 19096

United States

University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

SSM Health St. Mary's Hospital - Madison

Madison, Wisconsin 53715

United States