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)
Medtronic - MITG
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 practic…
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 UniversityNew Haven, Connecticut
- The University of South FloridaTampa, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Duke UniversityDurham, North Carolina
- The Ohio State University Wexner Medical CenterColumbus, Ohio
- Lankenau Institute for Medical ResearchWynnewood, Pennsylvania