A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
Inclusion Criteria:
- Suspected or confirmed NSCLC (up to and including Stage II)
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only
one lobe of the lung
- Performance status 0-1 (Eastern Cooperative Oncology Group classification)
- ASA score < 3
- No prior history of VATS or open lung surgery
- Willing to give consent and comply with study-related evaluation and treatment
schedule
Exclusion Criteria:
- Active bacterial infection or fungal infection;
- Systemic administration (intravenous or oral) of steroids (within 30 days prior to
study procedure)
- Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days
prior to the procedure
- Scheduled concurrent surgical procedure other than wedge resection or lobectomy
(central venous access - e.g. port placement, mediastinoscopy with lymph node
sampling, and VATS lymphadenectomy are allowed)
- Pregnancy
- Physical or psychological condition which would impair study participation;
- The patient is judged unsuitable for study participation by the Investigator for any
other reason; or
- Unable or unwilling to attend follow-up visits and examinations