Lung Cancer Clinical Trial

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

Summary

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.

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Eligibility Criteria

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 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.

Study is for people with:

Lung Cancer

Estimated Enrollment:

201

Study ID:

NCT02702921

Recruitment Status:

Completed

Sponsor:

Ethicon Endo-Surgery

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There is 1 Location for this study

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Emory University
Atlanta Georgia, 30322, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

201

Study ID:

NCT02702921

Recruitment Status:

Completed

Sponsor:


Ethicon Endo-Surgery

How clear is this clinincal trial information?

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