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Completed

NCT Number: NCT02500537

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.

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Key information

Conditions

Non-emergent, Abdominal or Thoracic Procedures

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's Hospital

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endo GIA™ Reinforced Reload with Tri-Staple™ Technology

Device

Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)

Primary outcomes

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

    Time frame: Through 30 Days

Secondary outcomes

  1. Staple Line Assessment: Incidence of Staple Line Bleeding

    Time frame: Day 0

    The incidence of staple line bleeding will be measured as ≥ 50 cc

  2. Staple Line Assessment: Incidence of Leakage

    Time frame: Day 0

    As measured by air leak test, or standard of care, as applicable

  3. Staple Line Assessment: Duration of Leakage, Post-Op

    Time frame: 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

  4. Staple Line Assessment: Incidence of Leakage; Post-Op

    Time frame: 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

  5. Staple Line Assessment: Incidence of Post-operative Infection

    Time frame: 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

  6. Staple Line Assessment:

    Time frame: 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

  7. Incidence of Repeat Hospital Admissions for Procedural-related Complications

    Time frame: 30 Days following procedure

    Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.