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/NCT06030180</url>
    </required_header>
    <id_info>
      <org_study_id>PR-0410</org_study_id>
      <nct_id>NCT06030180</nct_id>
    </id_info>
    <brief_title>CLUE: CLinical Utility Study of EsoGuard</brief_title>
    <acronym>PR-0410</acronym>
    <official_title>CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lucid Diagnostics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>PAVmed Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Utilize real-world data from the commercial use of EsoGuard testing on samples collected with&#xD;
        EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's&#xD;
        decision for endoscopy referral. Assess patient compliance with recommendations for upper&#xD;
        endoscopy, and relationship of compliance to positive EsoGuard results.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 23, 2023</start_date>
    <completion_date type="Anticipated">September 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2023</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>Clinical Utility</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Compliance</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Barrett Esophagus</condition>
    <condition>Barretts Esophagus With Dysplasia</condition>
    <condition>Esophagus Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Single Arm Study</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EsoGuard</intervention_name>
      <description>EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)</description>
      <arm_group_label>Single Arm Study</arm_group_label>
      <other_name>EsoGuard test on cells collected using EsoCheck</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG&#xD;
  &#xD;
            2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG&#xD;
               guidelines, or the AGA best practice advice from their 2022 clinical practice update.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Individuals who fall outside the eligible population defined by the EsoCheck device&#xD;
               Instructions For Use (IFU)&#xD;
  &#xD;
            2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE&#xD;
               screening&#xD;
  &#xD;
            3. Inability to provide written informed consent or participate in the required follow up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gisella Lopez</last_name>
      <role>Study Director</role>
      <affiliation>Lucid Diagnostics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexa Rueda</last_name>
      <phone>9157405766</phone>
      <email>axr@pavmed.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karyms Luna Miller</last_name>
      <email>klm@pavmed.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Arkansas Heartburn Treatment Center</name>
        <address>
          <city>Heber Springs</city>
          <state>Arkansas</state>
          <zip>72543</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beth Lister</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Arvada West Family Medicine,</name>
        <address>
          <city>Arvada</city>
          <state>Colorado</state>
          <zip>80004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laura Doanes</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Colorado Primary Healthcare</name>
        <address>
          <city>Littleton</city>
          <state>Colorado</state>
          <zip>80120</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ken Dole</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Savii Health</name>
        <address>
          <city>Savannah</city>
          <state>Georgia</state>
          <zip>31406</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wendy Blakenship</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>James E Race</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75224</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yolanda Torres</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Texas Digestive Specialists</name>
        <address>
          <city>Harlingen</city>
          <state>Texas</state>
          <zip>78550</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Roberto Olvera</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gastroenterology Partners of North Houston, PLLC</name>
        <address>
          <city>Shenandoah</city>
          <state>Texas</state>
          <zip>77384</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Erica Warren</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Premier Family Medical</name>
        <address>
          <city>Lindon</city>
          <state>Utah</state>
          <zip>84042</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Laura Esquivel</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Barrett Esophagus</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/NCT06030180
  org study id: PR-0410
  nct id: NCT06030180
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Utilize real-world data from the commercial use of EsoGuard testing on samples collected with
        EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's
        decision for endoscopy referral. Assess patient compliance with recommendations for upper
        endoscopy, and relationship of compliance to positive EsoGuard results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Clinical Utility
  time frame: Through study completion, an average of 1 year
  description: Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.
  measure: Patient Compliance
  time frame: Through study completion, an average of 1 year
  description: Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.
  arm group label: Single Arm Study
  arm group type: Other
  intervention type: Device
  intervention name: EsoGuard
  description: EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)
  arm group label: Single Arm Study
  other name: EsoGuard test on cells collected using EsoCheck
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Gisella Lopez
  role: Study Director
  affiliation: Lucid Diagnostics
  last name: Alexa Rueda
  phone: 9157405766
  email: axr@pavmed.com
  last name: Karyms Luna Miller
  email: klm@pavmed.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Barrett Esophagus
  sharing ipd: No