Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Device: Needle guiding robot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patients with untreatable/unmanageable coagulopathy Patients who are allergic to CT contrast media Patients with vascular invasion or extrahepatic metastases

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted Radiofrequency Ablation<br>CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot | Device: Needle guiding robot<br>* This intervention is to evaluate the safety and efficacy of a needle guiding robot for assisting targeting in CT-guided radiofrequency ablation of hepatocelluar carcinomas.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiation exposure (DLP, mGy*cm) | Sum of radiation exposures measured during the radiofrequency ablation | At time of radiofrequency ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of repositioning of radiofrequency electrode | Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor | At time of radiofrequency ablation | 
| Targeting error | Distance between the target and the electrode tip | At time of the 1st insertion of the electrode | 
| Procedure time | Total period of time from the installation of needle guiding robot to patient's transfer after the procedure | At time of radiofrequency ablation |