<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/NCT02185599</url>
  </required_header>
  <id_info>
    <org_study_id>IMPROVE-100</org_study_id>
    <nct_id>NCT02185599</nct_id>
  </id_info>
  <brief_title>IMproved PRactice Outcomes and Value Excellence in Colposcopy</brief_title>
  <acronym>IMPROVE-COLPO</acronym>
  <official_title>IMproved PRactice Outcomes and Value Excellence in Colposcopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DySIS Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DySIS Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will observe and quantify shifts in colposcopy practice and outcome improvements in&#xD;
      U.S. community-based cervical screening colposcopy examinations after the introduction of the&#xD;
      DySIS colposcope with Advanced Cervical Scan.&#xD;
&#xD;
      The study will collect colposcopy data across multiple sites in two arms; a prospective arm,&#xD;
      with DySIS being used for the examination and a retrospective arm, with data retrieved from&#xD;
      patient charts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each site will contribute data to both arms; the study will collect data on demographics,&#xD;
      disease yield, number of biopsies and treatment decisions. Study subjects will receive&#xD;
      standard of care procedures and management.&#xD;
&#xD;
      Prospective data will be collected at colposcopy examinations performed using the DySIS&#xD;
      digital colposcope on consecutive patients that have been referred for colposcopy after a&#xD;
      positive screening test. Retrospective data on colposcopy examinations performed using a&#xD;
      standard colposcope will be collected from patient medical records, to capture standard&#xD;
      practice to-date as a control for comparisons. The retrospective data will be collected from&#xD;
      consecutive examinations performed by the providers participating in the prospective arm and&#xD;
      for the preceding year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 9, 2017</completion_date>
  <primary_completion_date type="Actual">October 9, 2017</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects diagnosed with CIN2+ cervical lesions</measure>
    <time_frame>At time of colposcopy</time_frame>
    <description>Changes in number of subjects diagnosed with CIN2+ cervical lesions</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">7555</enrollment>
  <condition>High Grade Cervical Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>Colposcopy with DySIS</arm_group_label>
    <description>The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard colposcopy</arm_group_label>
    <description>The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DySIS</intervention_name>
    <description>Colposcopy performed with the DySIS digital colposcope</description>
    <arm_group_label>Colposcopy with DySIS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women referred for colposcopy after an abnormal screening test for prevention of cervical&#xD;
        cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females 21 years or older&#xD;
&#xD;
          2. Able to give informed consent&#xD;
&#xD;
          3. Referred for colposcopy with a screening test result that indicates the need for a&#xD;
             colposcopy, based on guidelines and practice:&#xD;
&#xD;
               -  HSIL, ASC-H, LSIL cytology&#xD;
&#xD;
               -  2x ASC-US cytology (25 or above)&#xD;
&#xD;
               -  2x/3x LSIL/ASC-US cytology (21-24)&#xD;
&#xD;
               -  ASC-US pap and hrHPV cotest/reflex&#xD;
&#xD;
               -  HPV 16/18 primary screening (≥25)&#xD;
&#xD;
               -  ASC-US pap after hrHPV&#xD;
&#xD;
               -  hrHPV x2 (≥30)&#xD;
&#xD;
               -  HPV16 or 16 after negative cytology/hrHPV (≥30)&#xD;
&#xD;
               -  Follow-up of CIN2/3 biopsy (younger women)&#xD;
&#xD;
               -  hrHPV and/or ≥ASC-US pap post-excision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical&#xD;
             neoplasia or other concurrent cancer&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency&#xD;
             syndrome (AIDS)&#xD;
&#xD;
          4. Referred for vulva/vaginal disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Oncology</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research-Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida OB GYN Associates, PA</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osceola Ob-Gyn, PA</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical research-Alpharetta</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research-Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Physicians Group- Heritage</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeside Ob/Gyn-Northeast Georgia Physician Group</name>
      <address>
        <city>Hoschton</city>
        <state>Georgia</state>
        <zip>30548</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nye Partners in Women's Health</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Illinois Masonic Medical Center - Creticos Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Center for Women's Healthcare</name>
      <address>
        <city>Elgin</city>
        <state>Illinois</state>
        <zip>60123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Women's Healthcare Specialists, SC</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providea Health Partners, LLC</name>
      <address>
        <city>Evergreen Park</city>
        <state>Illinois</state>
        <zip>60805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Wellness World</name>
      <address>
        <city>Hazel Crest</city>
        <state>Illinois</state>
        <zip>60429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Healthcare of Illinois</name>
      <address>
        <city>Mokena</city>
        <state>Illinois</state>
        <zip>60448</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Advanced Gynecologic Surgery Institute</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Center for Health</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Women's Healthcare Associates</name>
      <address>
        <city>Olympia Fields</city>
        <state>Illinois</state>
        <zip>60461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hinsdale &amp; Oak Brook Women's Clinic</name>
      <address>
        <city>Willowbrook</city>
        <state>Illinois</state>
        <zip>60527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OB-GYN Associates</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Margaret A. Smollen, MD, PC</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brodsky &amp; Taylor, PLC</name>
      <address>
        <city>Ferndale</city>
        <state>Michigan</state>
        <zip>48220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downriver Obstetrics &amp; Gynecology</name>
      <address>
        <city>Trenton</city>
        <state>Michigan</state>
        <zip>48183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NJ Gynecological Institute</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Healthcare of Princeton, LLC</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Beginnings, OB/GYN</name>
      <address>
        <city>Springfield</city>
        <state>New Jersey</state>
        <zip>07081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Gregory Shifrin, OB/GYN, PC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research-Cary</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research-Greensboro</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research- Central Carolina</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research- Mt Airy</name>
      <address>
        <city>Mount Airy</city>
        <state>North Carolina</state>
        <zip>27030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at Southview</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians &amp; Surgeons for Women, Inc</name>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Area OB-Gyn</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Bend Women's center</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura Bradford, MD</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Colinas OBGyn</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacArthur OB/GYN</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Women's Wellness</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeid Women's Health Center</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craig Ranch Ob/Gyn</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Ob-Gyn Associates</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr DeLeon's Women's Healthcare</name>
      <address>
        <city>Rowlett</city>
        <state>Texas</state>
        <zip>75088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Preferred Women's Healthcare Associates</name>
      <address>
        <city>Ridgeway</city>
        <state>Virginia</state>
        <zip>24148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colposcopy</keyword>
  <keyword>CIN</keyword>
  <keyword>cervical neoplasia</keyword>
  <keyword>cervical dysplasia</keyword>
  <keyword>cervical cancer</keyword>
  <keyword>CIN2+</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <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/NCT02185599
org study id: IMPROVE-100
nct id: NCT02185599
lead sponsor: 
has dmc: No
The study will observe and quantify shifts in colposcopy practice and outcome improvements in
      U.S. community-based cervical screening colposcopy examinations after the introduction of the
      DySIS colposcope with Advanced Cervical Scan.

      The study will collect colposcopy data across multiple sites in two arms; a prospective arm,
      with DySIS being used for the examination and a retrospective arm, with data retrieved from
      patient charts.
Each site will contribute data to both arms; the study will collect data on demographics,
      disease yield, number of biopsies and treatment decisions. Study subjects will receive
      standard of care procedures and management.

      Prospective data will be collected at colposcopy examinations performed using the DySIS
      digital colposcope on consecutive patients that have been referred for colposcopy after a
      positive screening test. Retrospective data on colposcopy examinations performed using a
      standard colposcope will be collected from patient medical records, to capture standard
      practice to-date as a control for comparisons. The retrospective data will be collected from
      consecutive examinations performed by the providers participating in the prospective arm and
      for the preceding year.
observational model: Other
time perspective: Other
measure: Number of subjects diagnosed with CIN2+ cervical lesions
time frame: At time of colposcopy
description: Changes in number of subjects diagnosed with CIN2+ cervical lesions
arm group label: Colposcopy with DySIS
description: The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
arm group label: Standard colposcopy
description: The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.
intervention type: Device
intervention name: DySIS
description: Colposcopy performed with the DySIS digital colposcope
arm group label: Colposcopy with DySIS
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Uterine Cervical Dysplasia