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

September 6, 2018 updated by: Hyung Jin Won, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyung Jin Won, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted Radiofrequency Ablation
CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total radiation exposure (DLP, mGy*cm)
Time Frame: At time of radiofrequency ablation
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
Time Frame: 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
At time of radiofrequency ablation
Targeting error
Time Frame: At time of the 1st insertion of the electrode
Distance between the target and the electrode tip
At time of the 1st insertion of the electrode
Procedure time
Time Frame: At time of radiofrequency ablation
Total period of time from the installation of needle guiding robot to patient's transfer after the procedure
At time of radiofrequency ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Ministry of Health & Welfare, Korea
Hyundai Heavy Industries

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

December 26, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Robin_RFA_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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