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Recruiting

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

NCT07351071 · Medtronic - MITG
In plain English

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Official title
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)
About this study
The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections. The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.
Eligibility criteria
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)
Study design
Enrollment target: 137 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-30
Estimated completion: 2027-06-30
Last updated: 2026-09-01
Interventions
Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
Primary outcomes
  • Incidence of anastomotic leak (within 30 days, +/- 14 days)
Sponsor
Medtronic - MITG · industry
Contacts & investigators
ContactYeshareg Yismaw · contact · yeshareg.g.yismaw@medtronic.com · +7635050079
ContactStudy Mailbox · contact · rs.securestudy@medtronic.com
InvestigatorKatharine Louise Jackson, MD, FACS, MBBS, MA · principal_investigator, Duke Raleigh Hospital
InvestigatorJohn Monson, MD, FACS · principal_investigator, Northwell Health
All locations (10)
Yale UniversityRecruiting
New Haven, Connecticut, United States
The University of South FloridaActive Not Recruiting
Tampa, Florida, United States
Wellstar HospitalNot Yet Recruiting
Marietta, Georgia, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Mayo ClinicNot Yet Recruiting
Rochester, Minnesota, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Lankenau Institute for Medical ResearchRecruiting
Wynnewood, Pennsylvania, United States
University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States
SSM Health St. Mary's Hospital - MadisonRecruiting
Madison, Wisconsin, United States