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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Digestive System Diseases; Gastrointestinal Diseases; Postoperative Complications; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Anastomotic Leak; Anastomotic Complication; Left-sided Colon Resection; Colorectal Anastomosis; Anastomotic Leaks
• Intervention / Treatment: Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

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.

• Study Type: Interventional
• Enrollment (Estimated): 137
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yeshareg Yismaw; Phone Number: +7635050079; Email: yeshareg.g.yismaw@medtronic.com
• Study Contact Backup: Name: Study Mailbox; Email: rs.securestudy@medtronic.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Not yet recruiting
      • Yale University
  • Florida
    • Tampa, Florida, United States, 33620
      • Recruiting
      • The University of South Florida
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Lankenau Institute for Medical Research
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Not yet recruiting
      • SSM Health St. Mary's Hospital - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left sided colon/colorectal procedure with creation of an anastomosis; single arm study, no control arm	Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system); Signia™ Circular Stapling system used for the creation of an anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 30 days, +/- 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anastomotic leaks	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.	within 90 days, +/- 14 days
Clinical significance of anastomotic leaks	Anastomotic leaks graded according to International Study Group of Rectal Cancer (ISGRC): Grade A: Anastomotic leakage results in no change in patients' management. Grade B: Leakage requires active therapeutic intervention but is manageable without re-laparotomy/operative intervention*. Grade C: Anastomotic leakage requires re-laparotomy/operative intervention*. *Operative intervention was added to the ISGRC definition for the purpose of this study.	within 90 days, +/- 14 days
Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)	Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.	Day 0 (day of surgery)
Incidence of anastomotic bleeding	bleeding at the anastomotic site that requires endoscopic or surgical intervention	within 30 and 90 days, +/- 14 days
Incidence of device-related adverse events	Adverse events related to Signia™ circular stapler and accessory components. An adverse event is defined as "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated."	within 90 days, +/- 14 days
Length of hospital stay	Length of hospital stay for the index procedure (from admission to discharge) after the Signia™ circular stapler was used in subjects undergoing left sided colon, sigmoid, or rectal resections	discharge (post-surgery up to 90 days, +/- 14 days)
Incidence of re-operation or surgical intervention	Incidence of re-operation or surgical intervention due to an adverse event related to the Signia™ circular stapler or accessory components	within 90 days, +/- 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon satisfaction	Surgeon satisfaction via a questionnaire	Day 0 (day of surgery)
Incidence of serious device-related adverse events	serious device-related adverse events related to Signia™ circular stapler and accessory components. A serious adverse event is defined as an "Adverse event that led to any of the following: Death,; Serious deterioration in the health of the subject, users or other persons as defined by one or more of the following:a life-threatening illness or injury, ora permanent impairment of a body structure or a body function including chronic diseases, orin-patient or prolonged hospitalization, ormedical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, or; foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment.	within 90 days, +/- 14 days
Clavien-Dindo classification of surgical complications	Clavien-Dindo classification of postoperative device related adverse events and serious device related adverse events.	within 90 days, +/- 14 days
Readmission to hospital	Readmission to hospital for study index procedure-related complications	within 30 and 90 day, +/- 14 days

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Katharine Louise Jackson, MD, FACS, MBBS, MA, Duke Raleigh Hospital; Principal Investigator: John Monson, MD, FACS, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rectal cancer; Anastomotic Leak; Low anterior resection; Colorectal Anastomosis; Left-sided Colon Resection; Circular stapler; Powered stapler
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Rectal Neoplasms; Intestinal Diseases; Anastomotic Leak; Postoperative Complications; Rectal Diseases
• Other Study ID Numbers: MDT24002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes