Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball
研究概览
简要总结
- To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
- To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
- To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.
详细描述
Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.
Operative Procedure:
Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.
Stage I-Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.
At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball
时间窗: Day 1
On day of surgery
Efficacy of the technique on surface liver tumors using saline lined RF Surface ablation.
时间窗: Day 1
On day of surgery
次要结局
- Determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion and a 2 cm depth with inflow occlusion.(Day 1)