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

Not Applicable

Completed

Interventions: Device: Surgeon's 'standard of care' stapler
Device: Ethicon Powered Vascular Stapler

Brief Summary: 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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Surgeon's 'standard of care' stapler	Surgeon's 'standard of care' stapler	Surgeon's current standard of care stapler
Ethicon Powered Vascular Stapler	Ethicon Powered Vascular Stapler	Ethicon Powered Vascular Stapler

Primary Outcome Measures

Name	Time	Method
Incidence of Intra-Operative Hemostatic Intervention	Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours	Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).

Secondary Outcome Measures

Name	Time	Method
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding	Post-Op through 4 Week Followup	Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).