NCT07351071 Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
| NCT ID | NCT07351071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic - MITG |
| Condition | Colorectal Anastomosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 137 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 137 participants in total. It began in 2025-12-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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)
Contact & Investigator
Katharine Louise Jackson, MD, FACS, MBBS, MA
PRINCIPAL INVESTIGATOR
Duke Raleigh Hospital
Frequently Asked Questions
Who can join the NCT07351071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Anastomosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07351071 currently recruiting?
Yes, NCT07351071 is actively recruiting participants. Contact the research team at yeshareg.g.yismaw@medtronic.com for enrollment information.
Where is the NCT07351071 trial being conducted?
This trial is being conducted at New Haven, United States, Tampa, United States, Boston, United States, Rochester, United States and 5 additional locations.
Who is sponsoring the NCT07351071 clinical trial?
NCT07351071 is sponsored by Medtronic - MITG. The principal investigator is Katharine Louise Jackson, MD, FACS, MBBS, MA at Duke Raleigh Hospital. The trial plans to enroll 137 participants.