A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Incidence of Intra-Operative Hemostatic Intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Surgeon's 'standard of care' stapler
Surgeon's current standard of care stapler
干预措施: Surgeon's 'standard of care' stapler (Device)
Ethicon Powered Vascular Stapler
Ethicon Powered Vascular Stapler
干预措施: Ethicon Powered Vascular Stapler (Device)
结局指标
主要结局
Incidence of Intra-Operative Hemostatic Intervention
时间窗: 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).
次要结局
- Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding(Post-Op through 4 Week Followup)