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

NCT03515811 | Completed Results FDA Device

• 1 other identifier: MDT17025SIG
• Study Type: observational
• Target: 136
• Locations: 5 countries
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (2)

• The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

  The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

  Up to and including 30 days intra- and post-operative.

• The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

  The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

  Up to and including 30 (+14) days post-procedure.

Secondary Outcomes (10)

• The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.

  Up to and including 30 (+14) days post-operative.

• The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).

  Up to and including 30 (+14) days post-operative.

• The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.

  Up to and including 30 (+14) days post-operative.

• The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

  Up to and including 30 (+14) days post-operative.

• The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.

  Up to and including 30 (+14) days post-operative.

Study Arms (2)

Abdominal

Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects).

Device: Signia™ Stapling System

Thoracic

Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects).

Device: Signia™ Stapling System

Interventions

Signia™ Stapling System DEVICE

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

Abdominal; Thoracic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

74 Thoracic subjects arm 53 abdominal subjects arm

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.
• a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
• b. 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (11)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

WakeMed Bariatric Specialists of North Carolina

Cary, North Carolina, 27518, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27710, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V4G5, Canada

Location

Azienda Ospedaleria San Gerardo

Monza, 20900, Italy

Location

Hospital Universitario del Rocio

Seville, 41009, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Blackpool Victoria Hospital

Blackpool, NE2 4NQ, United Kingdom

Location

MeSH Terms

Conditions

Abdominal Injuries; Thoracic Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiratory Tract Diseases

Limitations and Caveats

There were no limitations or caveats in this study.

Results Point of Contact

• Title: Andrea DiScipio, Senior Clinical Research Specialist
• Organization: Medtronic

andrea.l.discipio@medtronic.com

781-491-5350

Study Officials

• Kelley Kennedy

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: January 22, 2019
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: May 10, 2024
• Results First Posted: March 31, 2023

Record last verified: 2024-05

Locations

US (6); IT (1); GB (1); CA (1); ES (2)