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

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

Detailed Description
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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.

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

Conditions
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Non-emergent, Abdominal or Thoracic Procedures

Intervention / Treatment
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* Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be 18-80 years of age The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent 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. For thoracic subjects: the subject has a FEV1 ≥40% Exclusion Criteria: Subjects undergoing cardiac and vascular procedures The procedure is an emergency procedure The procedure is a revision/reoperation for the same indication 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) 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 opinion 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 an investigational drug or device research study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal Procedures<br>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<br>* Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)<br>|
| Experimental: Thoracic Procedures<br>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<br>* Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |