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

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Device: Needle guiding robot

• Registration Number: NCT03005756
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-29
• Study Start: 2017-01-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Patients with untreatable/unmanageable coagulopathy
• Patients who are allergic to CT contrast media
• Patients with vascular invasion or extrahepatic metastases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted Radiofrequency Ablation	Needle guiding robot	CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot

Primary Outcome Measures

Name	Time	Method
Total radiation exposure (DLP, mGy*cm)	At time of radiofrequency ablation	Sum of radiation exposures measured during the radiofrequency ablation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of