Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Condition(s) studied
Investigational drug(s) / intervention(s)
Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system): Signia™ Circular Stapling system used for the creation of an anastomosis
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of anastomotic leak — within 30 days, +/- 14 days
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.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University | New Haven | Connecticut | Recruiting |
| The University of South Florida | Tampa | Florida | Active Not Recruiting |
| Wellstar Hospital | Marietta | Georgia | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| Mayo Clinic | Rochester | Minnesota | Not Yet Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | Recruiting |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | Recruiting |
| University of Texas Health Science Center at Houston | Houston | Texas | Recruiting |
| SSM Health St. Mary's Hospital - Madison | Madison | Wisconsin | Recruiting |
More Medtronic - MITG trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07351071 on ClinicalTrials.gov ↗ ← All trials in the USA