A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

Inclusion criteria

• Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
• Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
• Performance status 0-1 (Eastern Cooperative Oncology Group classification);
• ASA score < 3;
• No prior history of VATS 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
• 18-75 years of age (inclusive).

Exclusion criteria

• Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
• Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
• Uncontrolled diabetes mellitus;
• End stage renal or liver disease;
• History of severe cardiovascular disease;
• FEV1% <50% or severe COPD;
• Prior chemotherapy or radiation for lung cancer;
• Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
• Robotic-assisted procedure;
• Women who are pregnant or lactating at the time of screening;
• Physical or psychological condition which would impair study participation;
• The subject is judged unsuitable for study participation by the Investigator for any other reason;
• Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
• Unable or unwilling to attend follow-up visits and examinations.