Single Center and Exploratory Investigator-initiated Trial to Evaluate the Safety and Efficacy of Needle Guiding Robot System for Radiofrequency Ablation in Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Total radiation exposure (DLP, mGy*cm)
研究概览
简要总结
The needle guiding robot helps targeting of radiofrequency ablation needles by matching computed tomography images and patients' bodies. Actual insertion of needles will be performed by doctors. This study evaluates the safety and efficacy of needle targeting on patients with hepatocellular carcinoma.
详细描述
A robotic system has been developed that includes a needle-path planning system and a needle-guiding robot arm with computed tomography (CT) guidance. The robot consists of robot base, 5-axis robot arm with guiding end-effector and path-planner. Optical tracking system with a custom-designed registration jig is used for the spatial registration and validation. Advantages of the robotic system would be accurate targeting with diverse angulation of the robot arm in CT-guided tumor ablation. Furthermore, robotic intervention might potentially decrease procedure time and radiation exposure to patients. The purpose of this clinical trial with patients with hepatocelluar carcinoma is to assess the safety and efficacy of our CT-guided needle-guiding robot.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with up to three Hepatocellular carcinomas (HCC) with no single HCC larger than 3 cm
- •Candidates for CT-guided radiofrequency ablation of HCC
- •Child-Pugh class A or B
排除标准
- •Patients with untreatable/unmanageable coagulopathy
- •Patients who are allergic to CT contrast media
- •Patients with vascular invasion or extrahepatic metastases
结局指标
主要结局
Total radiation exposure (DLP, mGy*cm)
时间窗: At time of radiofrequency ablation
Sum of radiation exposures measured during the radiofrequency ablation
次要结局
- Number of repositioning of radiofrequency electrode(At time of radiofrequency ablation)
- Targeting error(At time of the 1st insertion of the electrode)
- Procedure time(At time of radiofrequency ablation)
研究者
Hyung Jin Won
Associate Professor
Asan Medical Center