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RecruitingInterventional

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)

NCT ID: NCT07351071Sponsor: Medtronic - MITGLast updated: 2026-06-12

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.

Detailed description

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.

Arms & interventions

  • DeviceSignia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

    Signia™ Circular Stapling system used for the creation of an anastomosis

Outcome measures

Primary

  • Incidence of anastomotic leak

    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.

    Time frame: within 30 days, +/- 14 days

Secondary

  • Incidence of anastomotic leaks

    Time frame: within 90 days, +/- 14 days

  • Clinical significance of anastomotic leaks

    Time frame: within 90 days, +/- 14 days

  • Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)

    Time frame: Day 0 (day of surgery)

  • Incidence of anastomotic bleeding

    Time frame: within 30 and 90 days, +/- 14 days

  • Incidence of device-related adverse events

    Time frame: within 90 days, +/- 14 days

  • Length of hospital stay

    Time frame: discharge (post-surgery up to 90 days, +/- 14 days)

  • Incidence of re-operation or surgical intervention

    Time frame: within 90 days, +/- 14 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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)

Study locations (9)

Yale University

New Haven, Connecticut, 06520

Recruiting

The University of South Florida

Tampa, Florida, 33620

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Not Yet Recruiting

Mayo Clinic

Rochester, Minnesota, 55902

Not Yet Recruiting

Duke University

Durham, North Carolina, 27705

Recruiting

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Recruiting

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096

Recruiting

University of Texas Health Science Center at Houston

Houston, Texas, 77030

Recruiting

SSM Health St. Mary's Hospital - Madison

Madison, Wisconsin, 53715

Not Yet Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections | Cancerify