Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Recruiting · NCT07351071 · Interventional (participants receive a specific treatment) · Lead sponsor: Medtronic - MITG
View the official record on ClinicalTrials.gov →Interventions studied
Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 ≥ 18 years of age at time of consent
- Preoperative
Exclusion criteria
- Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- Subject with ASA classification ≥ IV
- Subject is pregnant (as determined by standard site practices)
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- 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
- Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
- Subject will undergo multiple synchronous colon resections
- 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)
- Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
- Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
- Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
- Any subject undergoing an ileal-anal pouch anastomosis surgery
- Intraoperative Exclusion Criteria
- Anastomosis not attempted with the Signia™ circular stapler
- Any subject for which the device is intended to be used outside the instructions for use (IFU)
Where it is running
9 locations listed across 9 US states.
- Yale University - New Haven, Connecticut, United States
- The University of South Florida - Tampa, Florida, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Duke University - Durham, North Carolina, United States
- The Ohio State University Wexner Medical Center - Columbus, Ohio, United States
- Lankenau Institute for Medical Research - Wynnewood, Pennsylvania, United States
- University of Texas Health Science Center at Houston - Houston, Texas, United States
- SSM Health St. Mary's Hospital - Madison - Madison, Wisconsin, United States