A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Ethicon Endo-Surgery
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Incidence of Intra-Operative Hemostatic Intervention
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Intra-Operative Hemostatic Intervention
Time Frame: 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 Outcomes
- Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding(Post-Op through 4 Week Followup)