CompletedNot applicableNCT02702921

Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies

This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.

Checked against the public recordLast updated Oct 11, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorEthicon Endo-Surgery
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Ethicon Endo-Surgery
Interventions being studied
Device: Surgeon's 'standard of care' stapler; Device: Ethicon Powered Vascular Stapler
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5; * 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 * Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment); * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory UniversityAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 11, 2018. Always confirm current availability with the study team.

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