CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Signia™ Stapling Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03515811
NCT03515811N/ACompleted
CompareCT.gov

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.

Medtronic - MITG·observational·Posted May 4, 2018·Updated May 10, 2024

In Brief

An observational study evaluating Signia™ Stapling System for Abdominal Injury and Thoracic Diseases. Completed, enrolled 136 participants across 11 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Injury, Thoracic Diseases
CountriesCanada, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 4, 2018
Enrollment StartJan 22, 2019
Primary CompletionJul 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.2 years ago

Interventions

Signia™ Stapling Systemdevice

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