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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500537
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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

Condition or disease Intervention/treatment Phase
Non-emergent, Abdominal or Thoracic Procedures Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500537


Locations
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United Kingdom
St Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Ahmed Ahmed, PhD, FRCS St Mary's Hospital, London
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02500537    
Other Study ID Numbers: COVRRBT0451
First Posted: July 16, 2015    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No