Trials / Recruiting

RecruitingNCT07351071

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in 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)

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 137 (estimated)

Sponsor: Medtronic - MITG · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections. The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.

Conditions

Interventions

Type	Name	Description
DEVICE	Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)	Signia™ Circular Stapling system used for the creation of an anastomosis

Timeline

Start date: 2025-12-30
Primary completion: 2026-12-31
Completion: 2027-02-28
First posted: 2026-01-20
Last updated: 2026-03-17

Locations

8 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07351071. Inclusion in this directory is not an endorsement.