Actively Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Led by Medtronic - MITG · Updated on 2026-03-17
137
Participants Needed
8
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older at the time of consent
- Patient is competent and willing to provide documented informed consent
- Patient is planned to undergo an elective left sided colon, sigmoid, or rectal procedure requiring an anastomosis created with the Signia12 circular stapler
You will not qualify if you...
- Patient is unable or unwilling to comply with study requirements or follow-up
- Patient has an ASA classification of IV or higher
- Patient is pregnant
- The procedure is an emergency surgery
- The procedure is a revision or reoperation for the same issue
- Patient has a medical condition that makes them unsuitable for the study or has a life expectancy under 6 months
- Patient is participating or plans to participate in another investigational drug or device study that could interfere
- Patient will have multiple synchronous colon resections
- Patient has a bleeding disorder or is on anticoagulant treatment that has not been reversed (except prophylaxis as part of surgery protocol)
- Patient has had chemotherapy or biologics within 6 weeks before the procedure
- Patient has a history of chronic corticosteroid use over 3 months within the past year
- Patient has chronic immunosuppression therapy over 3 months within the past year
- Patient is undergoing ileal-anal pouch anastomosis surgery
- Anastomosis is not attempted with the Signia12 circular stapler during surgery
- Use of the device outside of its instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Yale University
New Haven, Connecticut, United States, 06520
Not Yet Recruiting
2
The University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
4
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
5
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
6
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
7
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
8
SSM Health St. Mary's Hospital - Madison
Madison, Wisconsin, United States, 53715
Not Yet Recruiting
Research Team
Y
Yeshareg Yismaw
CONTACT
S
Study Mailbox
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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