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)
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.
Arms & interventions
- DeviceSignia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
Signia™ Circular Stapling system used for the creation of an anastomosis
Outcome measures
Primary
Incidence of anastomotic leak
Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis.
Time frame: within 30 days, +/- 14 days
Secondary
Incidence of anastomotic leaks
Time frame: within 90 days, +/- 14 days
Clinical significance of anastomotic leaks
Time frame: within 90 days, +/- 14 days
Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)
Time frame: Day 0 (day of surgery)
Incidence of anastomotic bleeding
Time frame: within 30 and 90 days, +/- 14 days
Incidence of device-related adverse events
Time frame: within 90 days, +/- 14 days
Length of hospital stay
Time frame: discharge (post-surgery up to 90 days, +/- 14 days)
Incidence of re-operation or surgical intervention
Time frame: within 90 days, +/- 14 days
Eligibility criteria
Study locations (9)
Yale University
New Haven, Connecticut, 06520
The University of South Florida
Tampa, Florida, 33620
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mayo Clinic
Rochester, Minnesota, 55902
Duke University
Durham, North Carolina, 27705
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
University of Texas Health Science Center at Houston
Houston, Texas, 77030
SSM Health St. Mary's Hospital - Madison
Madison, Wisconsin, 53715