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

Study acronym: SECURE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Dec 31, 2026 → Apr 30, 2027
See other at-risk trials from Medtronic - MITG

Record History

  1. Primary completion pushed from Dec 31, 2026 to Apr 30, 2027
    • Study completion pushed from Feb 28, 2027 to Jun 30, 2027
    • Study sites: 9 to 10
    v5
  2. Study sites: 8 to 9v4
  3. Site details revised at 2 of 8 sitesv3
  4. Study sites: 4 to 8v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07351071
Lead Sponsor Medtronic - MITG
Conditions
(from sponsor)		 Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases +3 more
Related terms Anastomotic Leak, Colonic Diseases, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Postoperative Complications, Rectal Diseases, Rectal Neoplasms
Enrollment 137 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov