Actively Recruiting
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)
Led by Medtronic - MITG · Updated on 2026-03-17
137
Participants Needed
8
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Signia12 circular stapler with Tri-Staple12 technology in patients undergoing elective left sided colon, sigmoid, or rectal resections. This study focuses on assessing the rate of anastomotic leaks within 30 days after surgery as the primary outcome, with additional safety and performance outcomes tracked up to 90 days post-procedure. The trial is designed to gather post-market data on the device in a real-world surgical setting. Participants will undergo an elective open or minimally invasive surgery where the Signia12 circular stapler is used to create an anastomosis. This is a single-arm study with no control group, and the device is applied during the surgical procedure. Researchers will monitor outcomes related to anastomotic leaks, bleeding, device deficiencies, adverse events, length of hospital stay, and need for re-operation or further surgical intervention. During the study, participants will be followed closely for up to 90 days after surgery. Evaluations include monitoring for anastomotic leaks and bleeding, device-related issues, and any additional surgical needs. Data collection will occur at specific time points up to 30 and 90 days post-surgery to assess safety and device performance. Participants' health status and recovery will be tracked throughout this period to gather comprehensive outcome data.
CONDITIONS
Brief 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...
- Subject is competent and willing to provide documented informed consent to participate in this clinical study
- 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
- Subject is 2018 years of age at time of consent
You will not qualify if you...
- Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- Subject with ASA classification 20 IV
- Subject is pregnant
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- Subject has a documented confounding medical condition or estimated life expectancy less than 6 months
- Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results
- Subject will undergo multiple synchronous colon resections
- Subject with a bleeding disorder or undergoing anticoagulant treatment that has not been reversed (prophylaxis allowed)
- Subject has undergone chemotherapy or received biologics within 6 weeks prior to procedure
- Subject has history of chronic corticosteroid use greater than 3 months within a year prior to procedure
- Subject has chronic immunosuppression therapy greater than 3 months within a year prior to procedure
- Subject undergoing ileal-anal pouch anastomosis surgery
- Anastomosis not attempted with the Signia circular stapler
- Device used outside instructions for use (IFU)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (day of surgery)
Participants undergo an elective left sided colon, sigmoid, or rectal resection with creation of an anastomosis using the Signia™ circular stapler with Tri-Staple™ Technology.
1 surgery visit
Duration - Up to 90 days post-surgery
Participants are followed for safety and performance outcomes including assessment of anastomotic leaks, device-related events, and recovery within 90 days after surgery.
Approximately 3 follow-up visits within 90 days
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
S
Study Mailbox
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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