xml: <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/NCT05978986</url>
    </required_header>
    <id_info>
      <org_study_id>17122021</org_study_id>
      <nct_id>NCT05978986</nct_id>
    </id_info>
    <brief_title>Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence</brief_title>
    <acronym>IVENUS</acronym>
    <official_title>Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</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>
        Purpose: To evaluate the sensitivity and specificity of the method for determining the&#xD;
        clinical class of chronic venous diseases using the Ivenus application (within C0-C2&#xD;
        according to CEAP).&#xD;
  &#xD;
        Materials and methods: Patients who applied to several phlebology clinics for an initial&#xD;
        consultation are consistently included in a multicenter prospective study. At the&#xD;
        appointment, a doctor with at least 5 years of experience takes photographs of the lower&#xD;
        extremities and uploads them to the IVENUS application, which automatically determines the&#xD;
        clinical class according to CEAP, without showing the results to the surgeon (blinding).&#xD;
        Further, the doctor independently determines the clinical class according to CEAP and enters&#xD;
        the data into the register.&#xD;
  &#xD;
        The object of the study is a photograph of a certain area of the lower limb.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 15, 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>Screening</primary_purpose>
      <masking>Double (Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determination of the sensitivity and specificity</measure>
      <time_frame>1 day</time_frame>
      <description>Determination of the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases according to the CEAP classification using the IVENUS application (within C0-C2 classes).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with complications</measure>
      <time_frame>1 day</time_frame>
      <description>Any serious adverse event will be recorded</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1530</enrollment>
    <condition>Varicose Veins of Lower Limb</condition>
    <condition>Telangiectasia</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Determining of the clinical class of chronic venous disorders by artificial intelligence</intervention_name>
      <description>The doctor takes pictures of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP. Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  C0-C2 CEAP clinical class;&#xD;
  &#xD;
            -  Signed consent to take part in investigation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  C3-C6 CEAP clinical class;&#xD;
  &#xD;
            -  Skin diseases of the lower extremities;&#xD;
  &#xD;
            -  Immobilization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Denis Borsuk</last_name>
      <role>Study Chair</role>
      <affiliation>VenoClinica, &quot;Vasculab&quot; ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Denis Borsuk</last_name>
      <phone>+79630777333</phone>
      <email>borsuk-angio@mail.ru</email>
    </overall_contact>
    <location>
      <facility>
        <name>Azbuka zdoroviya ltd.</name>
        <address>
          <city>Ekaterinburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexey Gasnikov</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Vasculab ltd.</name>
        <address>
          <city>Ekaterinburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Denis Borsuk</last_name>
        <phone>89630777333</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Phlebolog ltd.</name>
        <address>
          <city>Perm</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vladimir Denisov</last_name>
        <phone>89028330007</phone>
      </contact>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</investigator_affiliation>
      <investigator_full_name>Denis Borsuk</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Telangiectasis</mesh_term>
      <mesh_term>Varicose Veins</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978986
  org study id: 17122021
  nct id: NCT05978986
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: To evaluate the sensitivity and specificity of the method for determining the
        clinical class of chronic venous diseases using the Ivenus application (within C0-C2
        according to CEAP).
  
        Materials and methods: Patients who applied to several phlebology clinics for an initial
        consultation are consistently included in a multicenter prospective study. At the
        appointment, a doctor with at least 5 years of experience takes photographs of the lower
        extremities and uploads them to the IVENUS application, which automatically determines the
        clinical class according to CEAP, without showing the results to the surgeon (blinding).
        Further, the doctor independently determines the clinical class according to CEAP and enters
        the data into the register.
  
        The object of the study is a photograph of a certain area of the lower limb.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: Double (Care Provider, Investigator)
  measure: Determination of the sensitivity and specificity
  time frame: 1 day
  description: Determination of the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases according to the CEAP classification using the IVENUS application (within C0-C2 classes).
  measure: Number of participants with complications
  time frame: 1 day
  description: Any serious adverse event will be recorded
  intervention type: Diagnostic Test
  intervention name: Determining of the clinical class of chronic venous disorders by artificial intelligence
  description: The doctor takes pictures of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP. Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Denis Borsuk
  role: Study Chair
  affiliation: VenoClinica, "Vasculab" ltd.
  last name: Denis Borsuk
  phone: +79630777333
  email: borsuk-angio@mail.ru
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Russian Federation
  responsible party type: Principal Investigator
  investigator affiliation: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
  investigator full name: Denis Borsuk
  investigator title: Director
  mesh term: Telangiectasis
  mesh term: Varicose Veins
  sharing ipd: No