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

Thoracic Diseases Clinical Trial

Official title:
To Confirm the Safety and Performance of the Signia™ Stapling System Using Signia™ Intelligent Loading Units With Tri-Staple™ 2.0 Intelligent Reloads in Abdominal and Thoracic Procedures.

Clinical Trial 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.

Clinical Trial Description

This study will evaluate the use of Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads in indicated abdominal or thoracic procedures (e.g., resection, transection of tissue, and creation of anastomoses). Subjects who meet the eligibility criteria will be considered for study participation at a minimum of 10 sites and will be followed up to and including 30 days post-operative. Overall the study is estimated to progress for up to 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03515811
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase
Start date January 22, 2019
Completion date July 13, 2020
View Details
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