A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology

A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.

Study Overview

• Status: Completed
• Conditions: Non-emergent, Abdominal or Thoracic Procedures
• Intervention / Treatment: Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology

Detailed Description

The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must be 18-80 years of age
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 undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)

   • Thoracic procedures may include, but are not limited to, wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
   • Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
4. For thoracic subjects: the subject has a FEV1 ≥40%

Exclusion Criteria:

1. Subjects undergoing cardiac and vascular procedures
2. The procedure is an emergency procedure
3. The procedure is a revision/reoperation for the same indication

4. Any female subject who is pregnant

   a. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)

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 opinion 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 an investigational drug or device research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal Procedures; Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection. Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology	Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology; Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
Experimental: Thoracic Procedures; Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures. Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology	Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology; Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.	Through 30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staple Line Assessment: Incidence of Staple Line Bleeding	The incidence of staple line bleeding will be measured as ≥ 50 cc	Day 0
Staple Line Assessment: Incidence of Leakage	As measured by air leak test, or standard of care, as applicable	Day 0
Staple Line Assessment: Duration of Leakage, Post-Op	Duration of leakage based on chest tube drainage in days	Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Leakage; Post-Op	The incidence of leakage for abdominal procedures; Post-up	Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Post-operative Infection	Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients	Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment:	Number of additional intervention(s) to treat staple-line failure	Participants will be followed for the duration of hospital stay, on average up to 5 days post-op
Incidence of Repeat Hospital Admissions for Procedural-related Complications	Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure	30 Days following procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Ahmed Ahmed, PhD, FRCS, St Mary's Hospital, London

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COVRRBT0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO