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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Device: Surgeon's 'standard of care' stapler
* Device: Ethicon Powered Vascular Stapler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgeon's 'standard of care' stapler<br>Surgeon's current standard of care stapler | Device: Surgeon's 'standard of care' stapler<br> <br> |
| Experimental: Ethicon Powered Vascular Stapler<br>Ethicon Powered Vascular Stapler | Device: Ethicon Powered Vascular Stapler<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Intra-Operative Hemostatic Intervention | 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). | Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | 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). | Post-Op through 4 Week Followup |