<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/NCT03818620</url>
  </required_header>
  <id_info>
    <org_study_id>CI-PROT-0010</org_study_id>
    <secondary_id>B322201732457</secondary_id>
    <secondary_id>80M0675</secondary_id>
    <nct_id>NCT03818620</nct_id>
  </id_info>
  <brief_title>Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer</brief_title>
  <acronym>DermScan</acronym>
  <official_title>DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barco NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barco NV</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter prospective observational clinical investigation with a medical device.&#xD;
      The purpose of this study is to develop and validate of a new type of digital dermatoscope&#xD;
      with automatic decision support algorithms. By means of this study a better insight can be&#xD;
      gained of the current performance and workflow in clinical dermatoscopy. This knowledge will&#xD;
      be used to further improve the developed technology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI</measure>
    <time_frame>3.5 years</time_frame>
    <description>Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of new device to standard dermoscopy</measure>
    <time_frame>2 years</time_frame>
    <description>Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Skin Cancer</condition>
  <condition>Skin Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Barco digital dermatoscope device images</intervention_name>
    <description>Images of skin lesion taken with the Barco dermatoscope by site team member</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reference standard dermatoscope device images</intervention_name>
    <description>Images of skin lesion taken with a standard dermatoscope device (as part of standard care)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be considered for enrollment in the study when they have a lesion that is&#xD;
        accessible to the Barco Digital Dermatoscope, are able to give informed consent and are&#xD;
        over 18 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has a lesion that is accessible to the Barco Digital Dermatoscope&#xD;
&#xD;
          -  Patient gives informed consent&#xD;
&#xD;
          -  Men or women of any ethnic group aged ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men or women of any ethnic group aged &lt; 18 years&#xD;
&#xD;
          -  Patients not willing or able to read, understand and sign the study-specific informed&#xD;
             consent form&#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>Marjan Garmyn, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ / KU Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lieve Brochez, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Gent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hannah Manssens</last_name>
    <phone>056 26 2609</phone>
    <phone_ext>+32</phone_ext>
    <email>hannah.manssens@barco.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sofie Mylle</last_name>
      <phone>093326568</phone>
      <phone_ext>+32</phone_ext>
      <email>sofie.mylle@uzgent.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZ / KU Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sofie Van Kelst</last_name>
      <phone>016 37 21 17</phone>
      <phone_ext>+32</phone_ext>
      <email>sofie.vankelst@kuleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03818620
org study id: CI-PROT-0010
secondary id: B322201732457
secondary id: 80M0675
nct id: NCT03818620
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a multicenter prospective observational clinical investigation with a medical device.
      The purpose of this study is to develop and validate of a new type of digital dermatoscope
      with automatic decision support algorithms. By means of this study a better insight can be
      gained of the current performance and workflow in clinical dermatoscopy. This knowledge will
      be used to further improve the developed technology.
observational model: Other
time perspective: Prospective
measure: Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
time frame: 3.5 years
description: Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography
measure: Comparison of new device to standard dermoscopy
time frame: 2 years
description: Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)
intervention type: Device
intervention name: Barco digital dermatoscope device images
description: Images of skin lesion taken with the Barco dermatoscope by site team member
intervention type: Device
intervention name: Reference standard dermatoscope device images
description: Images of skin lesion taken with a standard dermatoscope device (as part of standard care)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marjan Garmyn, Prof. Dr.
role: Principal Investigator
affiliation: UZ / KU Leuven
last name: Lieve Brochez, Prof. Dr.
role: Principal Investigator
affiliation: UZ Gent
last name: Hannah Manssens
phone: 056 26 2609
phone ext: +32
email: hannah.manssens@barco.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Skin Neoplasms
mesh term: Skin Diseases