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

Asan Medical Center

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Device: Needle guiding robot

Study type: Interventional

Funder types: Other

Identifiers

NCT03005756

Robin_RFA_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Robot-assisted Radiofrequency Ablation

Experimental group

Description:

CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot

Treatment:

Device: Needle guiding robot