Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections (NCT07351071)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale University — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Yale University — New Haven, Connecticut
- The University of South Florida — Tampa, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Duke University — Durham, North Carolina
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- Lankenau Institute for Medical Research — Wynnewood, Pennsylvania
- University of Texas Health Science Center at Houston — Houston, Texas
- SSM Health St. Mary's Hospital - Madison — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (763) 505-0079
Email: yeshareg.g.yismaw@medtronic.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Colorectal Anastomosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.