Signia Circular Stapler Study for Colon, Sigmoid, and Rectal Resections
This study is looking at the safety and performance of the Signia™ circular stapler with Tri-Staple™ Technology. This device is used during surgery to connect parts of your colon (large intestine) or rectum after a section has been removed (left-sided colon, sigmoid, or rectal resections). The main goal is to see how often a leak occurs at the surgical connection (anastomotic leak) within 30 days. You may be able to join if you are 18 or older, are having one of these surgeries, and your doctor plans to use the Signia™ circular stapler. The study aims to enroll 137 participants.
- Study design
- This is an interventional study, meaning participants will receive the Signia™ circular stapler during their surgery. It plans to enroll 137 participants.
- What's involved
- You would undergo an elective left-sided colon/colorectal procedure where an anastomosis will be completed with the Signia™ circular stapler.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and performance outcomes will be assessed within 30 days and up to 90 days after using the Signia™ circular stapler.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
At a glance
Conditions
Where it's being run
9 sites across 9 statesStudy leadership
- Katharine Louise Jackson, MD, FACS, MBBS, MA · PRINCIPAL_INVESTIGATOR · Duke Raleigh Hospital
- John Monson, MD, FACS · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
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What this trial measures
- Incidence of anastomotic leakwithin 30 days, +/- 14 days
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.