A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
- The subject must be 18 years of age or older.
- The subject must be scheduled to undergo wedge resection or lobectomy via Video
Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically
proven to be primary lung cancer.
- The subject must be able to tolerate general anesthesia and have cardiopulmonary
reserve to tolerate the procedure.
- The subject must be willing and able to comply with all study requirements and have
understood and signed the informed consent.
- The subject is pregnant or breastfeeding.
- The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy,
pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected
interstitial lung disease.
- A rib-spreading thoracotomy incision is scheduled to be performed, however the use of
an access incision without rib-spreading for specimen removal or to facilitate hilar
dissection is allowed. VATS procedures that are converted in the operating room to
open procedures are not exclusionary.
- The subject has received pre-operative chemotherapy or radiation therapy for the lung
cancer that will be resected.
- The subject is scheduled to receive intra-operative brachytherapy.
- The subject has other severe illnesses that would preclude surgery such as unstable
angina or myocardial infarction within 3 months.
- Re-operative surgery is excluded if it is on the same side as the previous surgery.
- Investigator determines that participation in the study may jeopardize the safety or
welfare of the subject.
- The subject is unable to comply with the follow-up visit schedule