Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
NCT ID: NCT02702921
Last Updated: 2018-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2016-02-01
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgeon's 'standard of care' stapler
Surgeon's current standard of care stapler
Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler
Ethicon Powered Vascular Stapler
Ethicon Powered Vascular Stapler
Interventions
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Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler
Eligibility Criteria
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Inclusion Criteria
* Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
* Performance status 0-1 (Eastern Cooperative Oncology Group classification);
* American Society of Anesthesiologists (ASA) score \</= 3;
* No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 18 years of age.
Exclusion Criteria
* Pregnancy;
* Physical or psychological condition which would impair study participation; or
* The subject is judged unsuitable for study participation by the Investigator for any other reason.
18 Years
ALL
No
Sponsors
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Ethicon Endo-Surgery
INDUSTRY
Responsible Party
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Locations
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Emory University
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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ESC-15-001
Identifier Type: -
Identifier Source: org_study_id
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