Signia circular stapler for left-sided colon, sigmoid, and rectal resections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-market, multicenter study of the Signia circular stapler with Tri-Staple 2.0 circular reloads in adults undergoing elective left-sided colon, sigmoid, or rectal resections. The primary outcome is the incidence of anastomotic leak within 30 days, with additional safety and performance outcomes tracked through 90 days. Eligible participants are adults (≥18) scheduled for a planned anastomosis with the device who can consent and follow-up, while emergency procedures, revision operations, pregnancy, ASA class ≥IV, or limited life expectancy are excluded. The study is sponsored by Medtronic and conducted at several U.S. surgical centers with routine post-operative monitoring.

Why it matters

Who can join: the full rules

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)

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting
• Lankenau Institute for Medical Research
  Wynnewood, Pennsylvania, United States Recruiting
• University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting
• SSM Health St. Mary's Hospital - Madison
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Katharine Louise Jackson, MD, FACS, MBBS, MA — Duke Raleigh Hospital
• Study coordinator: Yeshareg Yismaw
• Email: yeshareg.g.yismaw@medtronic.com
• Phone: +7635050079

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.