Study to Assess Safety and Effectiveness of the Signia Circular Stapler with Tri-Staple Technology in Elective Left-sided Colon, Sigmoid, and Rectal Surgeries

What this Trial Is About

Researchers are evaluating the safety and performance of the Signia circular stapler, including its power handle, circular adapter, and Tri-Staple 2.0 circular reloads, in patients undergoing elective left-sided colon, sigmoid, or rectal resections. The study focuses on assessing the incidence of anastomotic leaks within 30 days after surgery and further safety outcomes within 90 days in a post-market setting. Participants will undergo surgery using the Signia circular stapler for creating anastomoses during their planned colon or rectal resections. This is a single-arm study without a control group, and the procedure may be performed either as an open or minimally invasive surgery. The study device is used during the operation, and outcomes are monitored over follow-up periods of up to 90 days. During the study, participants will be monitored closely for complications such as anastomotic leaks, bleeding, device-related adverse events, and the need for re-operation or additional surgical interventions. Hospital stay length and device deficiencies are also recorded. Follow-up assessments occur within 30 and 90 days post-surgery to evaluate safety and device performance, with the total participation lasting approximately three months after the procedure.

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