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

Not Applicable

Completed

Interventions: Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology

Brief Summary: A post-market study of the 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Thoracic Procedures	Endo GIA™ Reinforced Reload with Tri-Staple™ Technology	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
Abdominal Procedures	Endo GIA™ Reinforced Reload with Tri-Staple™ Technology	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

Primary Outcome Measures

Name	Time	Method
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

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