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

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.

NCT03515811•Medtronic - MITG

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
•2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
•3. The subject is scheduled to undergo an indicated primary abdominal or thoracic procedure for resection, transection and creation of anastomosis per the IFU where the Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate for the procedure only Medtronic buttresses can be used during the course of the study.
•3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
•3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion Criteria

•1. Subjects undergoing cardiac and vascular procedures.
•2. The procedure is an emergency procedure.
•3. The procedure is a revision/reoperation of a primary operation..
•4. Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
•5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
•6. The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
•7. The subject has comorbidities which, in the clinical judgment of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
•8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
•9. The subject is concurrently enrolled in another investigational drug or device research study or has been enrolled in another study within 30 days of enrollment.
•10. Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.

Locations (11)

Cedars Sinai Medical Center

Los Angeles, California, United States

Albany Medical College

Albany, New York, United States

WakeMed Bariatric Specialists of North Carolina

Cary, North Carolina, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Duke Regional Hospital

Durham, North Carolina, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

Azienda Ospedaleria San Gerardo

Monza, Italy

Hospital Universitario del Rocio

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Key Dates

Start Date

January 22, 2019

Primary Completion Date

July 13, 2020

Completion Date

July 13, 2020

Last Updated

May 10, 2024

Enrollment

136

ACTUAL participants

Conditions

Abdominal InjuryThoracic Diseases

Interventions

Signia™ Stapling System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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