<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/NCT03766633</url>
  </required_header>
  <id_info>
    <org_study_id>LV.2018.04.29</org_study_id>
    <nct_id>NCT03766633</nct_id>
  </id_info>
  <brief_title>Accuracy of the LiverVision® Semi-automated Liver Volumetry Software</brief_title>
  <acronym>LiverVision</acronym>
  <official_title>Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Free Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Free Hospital NHS Foundation Trust</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 LiverVision® software was designed to provide three-dimensional (3D) visualisation of the&#xD;
      liver using Computed Tomography (CT) scans. It provides semi-automated volumetry&#xD;
      measurements, vascular structure and territory tools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver volumetry has been widely used in liver surgery and living donor liver transplantation&#xD;
      to estimate the future liver remnant or the required liver volume for the recipient,&#xD;
      respectively.&#xD;
&#xD;
      Liver volumetry is typically performed using CT imaging with specially designed software.&#xD;
      Such manual measurements are time consuming and there is an ongoing debate whether the they&#xD;
      reflect the actual liver volume when performed by radiologists or surgeons as well as&#xD;
      according to the different software currently available in the market.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 29, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of the LiverVision® software volumetric measurements</measure>
    <time_frame>Baseline (CT performed prior to donation).</time_frame>
    <description>Accuracy of the LiverVision® software volumetric measurements assessed by correlation and agreement statistics with the manual volumetric measurements as well as the actual graph weight (reference standard).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Learning curve of the raters</measure>
    <time_frame>Baseline (CT performed prior to donation).</time_frame>
    <description>Assessment of the learning curve of the raters when using LiverVision® software assessed by the time required for the volumetric measurements and the accuracy of the results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Certainty and accuracy of the volumetric measurements.</measure>
    <time_frame>Baseline (CT performed prior to donation).</time_frame>
    <description>Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison</measure>
    <time_frame>Baseline (CT performed prior to donation).</time_frame>
    <description>Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>Living liver donors</arm_group_label>
    <description>This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liver volumetry of the graft on CT</intervention_name>
    <description>Preoperative liver volumetry using the CT images of the potential living liver donors.</description>
    <arm_group_label>Living liver donors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive living liver donors that underwent a CT prior to liver donation. The raters&#xD;
        will be 6 surgeons and 6 radiologists, both junior and senior.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18 years or older)&#xD;
&#xD;
          -  Living liver donors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Malago', MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Free Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitri A Raptis, MD, MSc, PhD</last_name>
    <phone>+447584560889</phone>
    <email>dimitri.raptis@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Massimo Malago', MD, PhD</last_name>
    <phone>+442077940500</phone>
    <email>massimo.malago@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnold Radke, MD, PhD</last_name>
      <phone>+497071290</phone>
      <email>arnoldradke@yahoo.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi</name>
      <address>
        <city>Ankara</city>
        <zip>06620</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deniz Balci, MD</last_name>
      <phone>+903125956000</phone>
      <email>denizbalci1@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Malagò, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Dimitri A Raptis, MD, MSc, PhD</last_name>
      <phone>+447584560889</phone>
      <email>dimitri.raptis@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://LiverVision.org/</url>
    <description>Data management platform for the LiverVision.org Study</description>
  </link>
  <link>
    <url>https://rBiostatistics.com/</url>
    <description>Cloud Graphical User Interface for R Statistics, the statistical analysis software</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Free Hospital NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dimitri Raptis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>LiverVision</keyword>
  <keyword>Liver</keyword>
  <keyword>Volumetry</keyword>
  <keyword>Semi-automated</keyword>
  <keyword>Living donor liver transplantation</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan for sharing individual participant data.</ipd_description>
  </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/NCT03766633
org study id: LV.2018.04.29
nct id: NCT03766633
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the
      liver using Computed Tomography (CT) scans. It provides semi-automated volumetry
      measurements, vascular structure and territory tools.
Liver volumetry has been widely used in liver surgery and living donor liver transplantation
      to estimate the future liver remnant or the required liver volume for the recipient,
      respectively.

      Liver volumetry is typically performed using CT imaging with specially designed software.
      Such manual measurements are time consuming and there is an ongoing debate whether the they
      reflect the actual liver volume when performed by radiologists or surgeons as well as
      according to the different software currently available in the market.
observational model: Cohort
time perspective: Retrospective
measure: Accuracy of the LiverVision® software volumetric measurements
time frame: Baseline (CT performed prior to donation).
description: Accuracy of the LiverVision® software volumetric measurements assessed by correlation and agreement statistics with the manual volumetric measurements as well as the actual graph weight (reference standard).
measure: Learning curve of the raters
time frame: Baseline (CT performed prior to donation).
description: Assessment of the learning curve of the raters when using LiverVision® software assessed by the time required for the volumetric measurements and the accuracy of the results.
measure: Certainty and accuracy of the volumetric measurements.
time frame: Baseline (CT performed prior to donation).
description: Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.
measure: Comparison
time frame: Baseline (CT performed prior to donation).
description: Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)
arm group label: Living liver donors
description: This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.
intervention type: Diagnostic Test
intervention name: Liver volumetry of the graft on CT
description: Preoperative liver volumetry using the CT images of the potential living liver donors.
arm group label: Living liver donors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Malago', MD, PhD
role: Principal Investigator
affiliation: Royal Free Hospital NHS Foundation Trust
last name: Dimitri A Raptis, MD, MSc, PhD
phone: +447584560889
email: dimitri.raptis@nhs.net
last name: Massimo Malago', MD, PhD
phone: +442077940500
email: massimo.malago@nhs.net
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
country: Turkey
country: United Kingdom
url: https://LiverVision.org/
description: Data management platform for the LiverVision.org Study
url: https://rBiostatistics.com/
description: Cloud Graphical User Interface for R Statistics, the statistical analysis software
responsible party type: Principal Investigator
investigator affiliation: Royal Free Hospital NHS Foundation Trust
investigator full name: Dimitri Raptis
investigator title: Principal Investigator
mesh term: Liver Diseases
sharing ipd: No
ipd description: There is no plan for sharing individual participant data.