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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:February 1, 2016
End Date:March 31, 2017

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A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in 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.


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.
We found this trial at
1
site
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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