A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
NCT ID: NCT02500537
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-05-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
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
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
Interventions
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Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmed Ahmed, PhD, FRCS
Role: PRINCIPAL_INVESTIGATOR
St Mary's Hospital, London
Locations
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St Mary's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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COVRRBT0451
Identifier Type: -
Identifier Source: org_study_id
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