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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Needle guiding robot
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot-assisted Radiofrequency Ablation

Arm Description

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

Outcomes

Primary Outcome Measures

Total radiation exposure (DLP, mGy*cm)
Sum of radiation exposures measured during the radiofrequency ablation

Secondary Outcome Measures

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
Targeting error
Distance between the target and the electrode tip
Procedure time
Total period of time from the installation of needle guiding robot to patient's transfer after the procedure

Full Information

First Posted
December 26, 2016
Last Updated
September 6, 2018
Sponsor
Asan Medical Center
Collaborators
Ministry of Health & Welfare, Korea, Hyundai Heavy Industries
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1. Study Identification

Unique Protocol Identification Number
NCT03005756
Brief Title
Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Ministry of Health & Welfare, Korea, Hyundai Heavy Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted Radiofrequency Ablation
Arm Type
Experimental
Arm Description
CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot
Intervention Type
Device
Intervention Name(s)
Needle guiding robot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total radiation exposure (DLP, mGy*cm)
Description
Sum of radiation exposures measured during the radiofrequency ablation
Time Frame
At time of radiofrequency ablation
Secondary Outcome Measure Information:
Title
Number of repositioning of radiofrequency electrode
Description
Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor
Time Frame
At time of radiofrequency ablation
Title
Targeting error
Description
Distance between the target and the electrode tip
Time Frame
At time of the 1st insertion of the electrode
Title
Procedure time
Description
Total period of time from the installation of needle guiding robot to patient's transfer after the procedure
Time Frame
At time of radiofrequency ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Do Lee, MD, PhD
Phone
82-2-3010-3013
Email
webmaster@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Do Lee, MD, PhD
Phone
82-2-3010-3013
Email
webmaster@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Hyung Jin Won, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24220755
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.
Results Reference
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PubMed Identifier
23928933
Citation
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.
Results Reference
background
PubMed Identifier
25189152
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.
Results Reference
background

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

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