<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/NCT03840187</url>
  </required_header>
  <id_info>
    <org_study_id>0097-18-BRZ</org_study_id>
    <nct_id>NCT03840187</nct_id>
  </id_info>
  <brief_title>Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System</brief_title>
  <official_title>Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barzilai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barzilai Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Correlation between colposcopist findings and digital cervicography employing Gynescope&#xD;
      system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 30 women that will be referred for colposcopy examination at the standard indications&#xD;
      will also undergo a colposcopy examination of the cervix by a gynescope. The physicain&#xD;
      performing the optical test will record the findings in accordance with the International&#xD;
      Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable&#xD;
      will be included in every record. At later stage, the images obtained by the cervicography&#xD;
      will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between&#xD;
      the categorical findings in both assesments will be compared. The correlation measure will be&#xD;
      performed by Kappa test according to the categorial result of both measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy</measure>
    <time_frame>5 months</time_frame>
    <description>leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels</description>
  </primary_outcome>
  <enrollment type="Actual">29</enrollment>
  <condition>Cervical Dysplasia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Digital cervicography</intervention_name>
    <description>Colposcopist findings and digital cervicography employing Gynescope system</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients reffered for colposcopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients reffered for colposcopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient refusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ofer Gemer, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barzilai University Medical Center Ashkelon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barzilay University Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital cervicography</keyword>
  <keyword>Gynescope system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</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/NCT03840187
org study id: 0097-18-BRZ
nct id: NCT03840187
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Correlation between colposcopist findings and digital cervicography employing Gynescope
      system
Up to 30 women that will be referred for colposcopy examination at the standard indications
      will also undergo a colposcopy examination of the cervix by a gynescope. The physicain
      performing the optical test will record the findings in accordance with the International
      Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable
      will be included in every record. At later stage, the images obtained by the cervicography
      will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between
      the categorical findings in both assesments will be compared. The correlation measure will be
      performed by Kappa test according to the categorial result of both measurements.
observational model: Cohort
time perspective: Prospective
measure: Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy
time frame: 5 months
description: leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels
intervention type: Diagnostic Test
intervention name: Digital cervicography
description: Colposcopist findings and digital cervicography employing Gynescope system
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
last name: Ofer Gemer, Professor
role: Principal Investigator
affiliation: Barzilai University Medical Center Ashkelon
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Uterine Cervical Dysplasia