A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Intra-Operative Hemostatic Interventions
研究概览
简要总结
The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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 IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
- •Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- •ASA score < 3;
- •No prior history of VATS 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
- •18-75 years of age (inclusive).
排除标准
- •Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
- •Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
- •Uncontrolled diabetes mellitus;
- •End stage renal or liver disease;
- •History of severe cardiovascular disease;
- •FEV1% <50% or severe COPD;
- •Prior chemotherapy or radiation for lung cancer;
- •Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
- •Robotic-assisted procedure;
- •Women who are pregnant or lactating at the time of screening;
- •Physical or psychological condition which would impair study participation;
- •The subject is judged unsuitable for study participation by the Investigator for any other reason;
- •Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
- •Unable or unwilling to attend follow-up visits and examinations.
研究组 & 干预措施
Powered vascular stapler
Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
干预措施: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler (Device)
结局指标
主要结局
Incidence of Intra-Operative Hemostatic Interventions
时间窗: Intra-Operative
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of 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).
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
时间窗: Post-op through 4 week follow-up
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 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).
次要结局
未报告次要终点