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

Medtronic

Status: Completed

Conditions: Non-emergent, Abdominal or Thoracic Procedures

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02500537

COVRRBT0451

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Abdominal Procedures

Experimental group

Description:

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

Treatment:

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

Thoracic Procedures

Experimental group

Description:

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

Treatment:

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