Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
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
Interventions
Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
Conditions
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