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

NCT07351071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Colorectal Anastomosis
  • Left-sided Colon Resection
  • Anastomotic Leak
  • Anastomotic Complication
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Colonic Diseases
  • Intestinal Diseases
  • Rectal Diseases
  • Postoperative Complications
  • Anastomotic Leaks

Interventions

DEVICE

Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

Signia™ Circular Stapling system used for the creation of an anastomosis

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Katharine Louise Jackson, MD, FACS, MBBS, MA · Duke Raleigh Hospital

  • John Monson, MD, FACS · Northwell Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2027-04-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07351071 on ClinicalTrials.gov