First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- To demonstrate the feasibility of the liver PILP intervention.
研究概览
简要总结
The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.
详细描述
The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.
The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
- •Unresectable metastatic disease predominant in the liver
排除标准
- •More than 60 % tumor involved liver tissue
- •Abnormal vascular anatomy
- •Severe atherosclerosis
- •Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
- •Short suprahepatic vena cava segment (< 1.5 cm)
- •One or both jugular veins are occluded
- •Other severe, concomitant diseases regarding the subject status
结局指标
主要结局
To demonstrate the feasibility of the liver PILP intervention.
时间窗: During intervention and up to 30 days post intervention
The liver PILP intervention will be considered feasible if the intervention is demonstrated to be safe and the PILP kit performs according to specifications related to localization, flow rates and retrieval of devices.
次要结局
未报告次要终点