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

Completed · Not applicable

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02702921

Run by

Ethicon Endo-Surgery

People needed

201

Starts

2016-02-01

Expected to finish

2017-03-31

Last updated by the study team

2018-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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