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A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

NCT03515811 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136

Last updated 2024-05-10

Study results available
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Summary

The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.

Conditions

  • Abdominal Injury
  • Thoracic Diseases

Interventions

DEVICE

Signia™ Stapling System

Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Kelley Kennedy · Medtronic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2020-07-13
Completion
2020-07-13
FDA Device
Yes

Countries

  • United States
  • Canada
  • Italy
  • Spain
  • United Kingdom

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 NCT03515811 on ClinicalTrials.gov