A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
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 renal artery and renal 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
- •Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
- •American Society of Anesthesiologists (ASA) score < 3;
- •No prior history of partial or wedge nephrectomy (on the kidney 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 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
Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
时间窗: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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
- Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding(Post-Op through 4 Week Follow-up)