<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/NCT03796871</url>
  </required_header>
  <id_info>
    <org_study_id>6798</org_study_id>
    <nct_id>NCT03796871</nct_id>
  </id_info>
  <brief_title>Medical Device Based on Polarized Light for Cutaneous Lesions Visualization</brief_title>
  <acronym>DERMAPOL</acronym>
  <official_title>Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions&#xD;
      thus is a priority. The diagnosis gold standard is based on the combination of clinical and&#xD;
      histopathological examinations. Nevertheless, the clinical examination is not sufficiently&#xD;
      effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid&#xD;
      unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help&#xD;
      dermatologists in diagnosing skin lesions.&#xD;
&#xD;
      This medical device combined with its software is a strong and ergonomic spectro-polarimetric&#xD;
      imager instrument. It can realize images of the superficial cutaneous tissues and&#xD;
      subcutaneous tissues close to the surface by exploiting polarized light properties.&#xD;
&#xD;
      This first clinical trial aims to demonstrate that this medical device is able to segment&#xD;
      effectively healthy and tumor tissues and that it can correlate main semiological elements&#xD;
      (identified thanks to the clinical and histopathological examinations) to the physico-optical&#xD;
      characteristics obtained on the images of the medical device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2019</start_date>
  <completion_date type="Anticipated">January 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 14, 2024</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of lesions with semiological characteristics</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physico-optical description of the lesions</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Physico-optical description of the cutaneous lesions by the medical device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of different semiological characteristics</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of semiological characteristics properly identified</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Proportion of semiological characteristics properly identified by the medical device for all lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity, sensitivity and predictive values</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis</measure>
    <time_frame>Before biopsy</time_frame>
    <description>Proportion of cases with same semiological characteristics list</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Skin Lesion</condition>
  <arm_group>
    <arm_group_label>Dermapol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the experimental medical device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermapol</intervention_name>
    <description>Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording</description>
    <arm_group_label>Dermapol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patient with a skin tumor (benign or cancerous) which has to be excised and&#xD;
             analysed according to histopathological examination&#xD;
&#xD;
          -  skin lesion belonging to one of these groups (diagnosed by clinical examination):&#xD;
&#xD;
               -  cutaneous cyst&#xD;
&#xD;
               -  seborrhoeic keratosis&#xD;
&#xD;
               -  cutaneous carcinoma&#xD;
&#xD;
               -  naevus&#xD;
&#xD;
               -  melanoma&#xD;
&#xD;
               -  actinic keratosis and cutaneous horn&#xD;
&#xD;
               -  other skin tumors&#xD;
&#xD;
          -  skin lesion size equal to or less than 5 cm&#xD;
&#xD;
          -  signed written consent form&#xD;
&#xD;
          -  patient affiliated to a social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  skin lesion size strictly over than 5 cm&#xD;
&#xD;
          -  eyelid lesion&#xD;
&#xD;
          -  aluminium, POM (polyoxymethylene) or organic glass allergy&#xD;
&#xD;
          -  known pregnancy, breast-feeding&#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>Bernard CRIBIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas MEYER, MD</last_name>
    <phone>3 88 11 63 32</phone>
    <phone_ext>+33</phone_ext>
    <email>nicolas.meyer@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernard Cribier, MD</last_name>
      <phone>88 11 61 80</phone>
      <phone_ext>+33</phone_ext>
      <email>bernard.cribier@chru-strasbourg.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03796871
org study id: 6798
nct id: NCT03796871
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions
      thus is a priority. The diagnosis gold standard is based on the combination of clinical and
      histopathological examinations. Nevertheless, the clinical examination is not sufficiently
      effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid
      unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help
      dermatologists in diagnosing skin lesions.

      This medical device combined with its software is a strong and ergonomic spectro-polarimetric
      imager instrument. It can realize images of the superficial cutaneous tissues and
      subcutaneous tissues close to the surface by exploiting polarized light properties.

      This first clinical trial aims to demonstrate that this medical device is able to segment
      effectively healthy and tumor tissues and that it can correlate main semiological elements
      (identified thanks to the clinical and histopathological examinations) to the physico-optical
      characteristics obtained on the images of the medical device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Proportion of lesions with semiological characteristics
time frame: Before biopsy
description: Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
measure: Physico-optical description of the lesions
time frame: Before biopsy
description: Physico-optical description of the cutaneous lesions by the medical device
measure: Number of different semiological characteristics
time frame: Before biopsy
description: Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing
measure: Proportion of semiological characteristics properly identified
time frame: Before biopsy
description: Proportion of semiological characteristics properly identified by the medical device for all lesions
measure: Specificity, sensitivity and predictive values
time frame: Before biopsy
description: Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations
measure: Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis
time frame: Before biopsy
description: Proportion of cases with same semiological characteristics list
arm group label: Dermapol
arm group type: Experimental
description: Use of the experimental medical device
intervention type: Device
intervention name: Dermapol
description: Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
arm group label: Dermapol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard CRIBIER, MD
role: Principal Investigator
affiliation: Hôpitaux Universitaires de Strasbourg
last name: Nicolas MEYER, MD
phone: 3 88 11 63 32
phone ext: +33
email: nicolas.meyer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No