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

Completed

Conditions studied: Abdominal Injury, Thoracic Diseases

In brief

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.

Key facts

Study ID

NCT03515811

Run by

Medtronic - MITG

People needed

136

Starts

2019-01-22

Expected to finish

2020-07-13

Last updated by the study team

2024-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
• The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
• 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).

You may not qualify if…

• Subjects undergoing cardiac and vascular procedures.
• The procedure is an emergency procedure.
• The procedure is a revision/reoperation of a primary operation..
• 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.
• Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
• The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
• 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.
• The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
• 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.
• Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.

Where it is running

• 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
• Blackpool Victoria Hospital — Blackpool, United Kingdom

Full record on ClinicalTrials.gov

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