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.

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 Overview

• Status: Completed
• Conditions: Thoracic Diseases; Abdominal Injury
• Intervention / Treatment: Device: Signia™ Stapling System

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.

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
• Italy
  • Monza, Italy, 20900
    • Azienda Ospedaleria San Gerardo
• Spain
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41009
    • Hospital Universitario del Rocio
• United Kingdom
  • Blackpool, United Kingdom, NE2 4NQ
    • Blackpool Victoria Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • WakeMed Bariatric Specialists of North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke Regional Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

74 Thoracic subjects arm 53 abdominal subjects arm

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abdominal; Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects).	Device: Signia™ Stapling System; Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
Thoracic; Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects).	Device: Signia™ Stapling System; Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Resulted in a life-threatening illness or injury, or; Resulted in a permanent impairment of a body structure or a body function, or; In-patient or prolonged hospitalization, or; 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: Resulted in a life-threatening illness or injury, or; Resulted in a permanent impairment of a body structure or a body function, or; In-patient or prolonged hospitalization, or; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.	The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.	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).	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.	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.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as > 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.	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.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.	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.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.	Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.	Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered >7 days in duration.	Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.	Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.	Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.	The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.	Up to and including 30 (+14) days post-operative.

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Director: Kelley Kennedy, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Wounds and Injuries; Thoracic Diseases; Abdominal Injuries
• Other Study ID Numbers: MDT17025SIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes