<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005756</url>
  </required_header>
  <id_info>
    <org_study_id>Robin_RFA_01</org_study_id>
    <nct_id>NCT03005756</nct_id>
  </id_info>
  <brief_title>Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients</brief_title>
  <acronym>NGR</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health &amp; Welfare, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hyundai Heavy Industries</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The needle guiding robot helps targeting of radiofrequency ablation needles by matching&#xD;
      computed tomography images and patients' bodies. Actual insertion of needles will be&#xD;
      performed by doctors. This study evaluates the safety and efficacy of needle targeting on&#xD;
      patients with hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A robotic system has been developed that includes a needle-path planning system and a&#xD;
      needle-guiding robot arm with computed tomography (CT) guidance. The robot consists of robot&#xD;
      base, 5-axis robot arm with guiding end-effector and path-planner. Optical tracking system&#xD;
      with a custom-designed registration jig is used for the spatial registration and validation.&#xD;
      Advantages of the robotic system would be accurate targeting with diverse angulation of the&#xD;
      robot arm in CT-guided tumor ablation. Furthermore, robotic intervention might potentially&#xD;
      decrease procedure time and radiation exposure to patients. The purpose of this clinical&#xD;
      trial with patients with hepatocelluar carcinoma is to assess the safety and efficacy of our&#xD;
      CT-guided needle-guiding robot.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total radiation exposure (DLP, mGy*cm)</measure>
    <time_frame>At time of radiofrequency ablation</time_frame>
    <description>Sum of radiation exposures measured during the radiofrequency ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of repositioning of radiofrequency electrode</measure>
    <time_frame>At time of radiofrequency ablation</time_frame>
    <description>Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Targeting error</measure>
    <time_frame>At time of the 1st insertion of the electrode</time_frame>
    <description>Distance between the target and the electrode tip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>At time of radiofrequency ablation</time_frame>
    <description>Total period of time from the installation of needle guiding robot to patient's transfer after the procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Robot-assisted Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Needle guiding robot</intervention_name>
    <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.</description>
    <arm_group_label>Robot-assisted Radiofrequency Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with up to three Hepatocellular carcinomas (HCC) with no single HCC larger&#xD;
             than 3 cm&#xD;
&#xD;
          -  Candidates for CT-guided radiofrequency ablation of HCC&#xD;
&#xD;
          -  Child-Pugh class A or B&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with untreatable/unmanageable coagulopathy&#xD;
&#xD;
          -  Patients who are allergic to CT contrast media&#xD;
&#xD;
          -  Patients with vascular invasion or extrahepatic metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sang Do Lee, MD, PhD</last_name>
    <phone>82-2-3010-3013</phone>
    <email>webmaster@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang Do Lee, MD, PhD</last_name>
      <phone>82-2-3010-3013</phone>
      <email>webmaster@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Hyung Jin Won, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>24220755</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23928933</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25189152</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Hyung Jin Won</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005756
org study id: Robin_RFA_01
nct id: NCT03005756
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total radiation exposure (DLP, mGy*cm)
time frame: At time of radiofrequency ablation
description: Sum of radiation exposures measured during the radiofrequency ablation
measure: Number of repositioning of radiofrequency electrode
time frame: At time of radiofrequency ablation
description: Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor
measure: Targeting error
time frame: At time of the 1st insertion of the electrode
description: Distance between the target and the electrode tip
measure: Procedure time
time frame: At time of radiofrequency ablation
description: Total period of time from the installation of needle guiding robot to patient's transfer after the procedure
arm group label: Robot-assisted Radiofrequency Ablation
arm group type: Experimental
description: CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot
intervention type: Device
intervention name: Needle guiding robot
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.
arm group label: Robot-assisted Radiofrequency Ablation
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sang Do Lee, MD, PhD
phone: 82-2-3010-3013
email: webmaster@amc.seoul.kr
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
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.
PMID: 24220755
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.
PMID: 23928933
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.
PMID: 25189152
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Hyung Jin Won
investigator title: Associate Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No