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

Carcinoma, Hepatocellular Clinical Trial

— NGR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03005756
• Other study ID #: Robin_RFA_01
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: March 2019

Study information

• Verified date: September 2018
• Source: Asan Medical Center
• Contact: Sang Do Lee, MD, PhD
• Phone: 82-2-3010-3013
• Email: webmaster[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Device:
• Needle guiding robot
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Hyundai Heavy Industries, Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robot-assisted radiofrequency ablation of primary and secondary liver tumours: early experience. Eur Radiol. 2014 Jan;24(1):79-85. doi: 10.1007/s00330-013-2979-7. Epub 2013 Aug 9. — View Citation

Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robotic-assisted thermal ablation of liver tumours. Eur Radiol. 2015 Jan;25(1):246-57. doi: 10.1007/s00330-014-3391-7. Epub 2014 Sep 5. — View Citation

Koethe Y, Xu S, Velusamy G, Wood BJ, Venkatesan AM. Accuracy and efficacy of percutaneous biopsy and ablation using robotic assistance under computed tomography guidance: a phantom study. Eur Radiol. 2014 Mar;24(3):723-30. doi: 10.1007/s00330-013-3056-y. Epub 2013 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radiation exposure (DLP, mGy*cm)	Sum of radiation exposures measured during the radiofrequency ablation	At time of radiofrequency ablation
Secondary	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
Secondary	Targeting error	Distance between the target and the electrode tip	At time of the 1st insertion of the electrode
Secondary	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