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 |
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.
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 = 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.
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