Signia circular stapler for left-sided colon, sigmoid, and rectal resections
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)
This study will try the Signia circular stapler with Tri-Staple technology to see if it safely creates bowel reconnections in adults having left-sided colon, sigmoid, or rectal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 137 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic - MITG Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (New Haven, Connecticut and 7 other locations) |
| Trial ID | NCT07351071 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) scheduled for an elective left-sided colon, sigmoid, or rectal resection that will include a circular anastomosis, who can provide informed consent and attend follow-up visits, are the ideal candidates.
Not a fit: Patients having emergency surgery, revision/reoperation for the same indication, those who are pregnant, have ASA class IV or higher, have a life expectancy under six months, or cannot comply with follow-up are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the device could lower anastomotic leak rates and related complications, leading to safer recoveries after left-sided colorectal surgery.
How similar studies have performed: Circular staplers with multi-row staple technologies are widely used and prior device and post-market data generally support their safety, but this study gathers specific outcomes for the Signia system.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New Haven, Connecticut and 7 other locations
- Yale University — New Haven, Connecticut, United States (Not_yet_recruiting)
- The University of South Florida — Tampa, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Not_yet_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 (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.