Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
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
Sex
ALL
Min age
18 Years
Max age
—
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 practices)
4. The procedure is an emergency procedure
5. The procedure is a revision/reoperation for the same indication
6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
8. Subject will undergo multiple synchronous colon resections
9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
13. Any subject undergoing an ileal-anal pouch anastomosis surgery
Intraoperative Exclusion Criteria
1. Anastomosis not attempted with the Signia™ circular stapler
2. Any subject for which the device is intended to be used outside the instructions for use (IFU)
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
Official registry record
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.
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