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/NCT05965999</url>
    </required_header>
    <id_info>
      <org_study_id>LUD-PR-0421</org_study_id>
      <nct_id>NCT05965999</nct_id>
    </id_info>
    <brief_title>Lucid Registry Study</brief_title>
    <acronym>Lucid Registry</acronym>
    <official_title>A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma</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>
        This is a multicenter, prospective, observational study designed to capture a limited set of&#xD;
        data consisting of diagnostic test results and clinical management information on subjects&#xD;
        who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for&#xD;
        EsoGuard results to be available, as well as for any subsequent clinical evaluation to have&#xD;
        been performed (e.g., upper endoscopy and any initial therapeutic management), study staff&#xD;
        will obtain the desired information and record it in an electronic data collection (EDC)&#xD;
        system, pertaining to subject demographics, pertinent medical history, and risk factors for&#xD;
        BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient&#xD;
        tolerance, (2) EsoGuard test result; (3) initial clinical management including upper&#xD;
        endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist&#xD;
        assessing any biopsies taken), as well as (4) additional clinical management and/or a&#xD;
        therapeutic procedure(s) performed. The time point for collecting such information shall be&#xD;
        fluid, depending on the time course of care provided subsequent to the EsoGuard result being&#xD;
        available. It is expected typically to be approximately 4 months given the systemic delays in&#xD;
        scheduling and performing upper endoscopies and obtaining biopsy results. There is no a&#xD;
        priori limit on the timeline for obtaining these data, but it is . anticipated that all data&#xD;
        collection will be completed within 8 months of the availability of EsoGuard results.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 11, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>4 Months</target_duration>
    <primary_outcome>
      <measure>Agreement between positive EsoGuard test results and upper endoscopy diagnosis (i.e., subjects with BE/EAC newly diagnosed by upper endoscopy)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of subjects with a positive EsoGuard test</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Agreement between negative EsoGuard test results and upper endoscopy diagnosis (i.e., subjects determined not to have BE/EAC on upper endoscopy)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Barrett Esophagus</condition>
    <condition>Esophageal Adenocarcinoma</condition>
    <condition>Barretts Esophagus With Dysplasia</condition>
    <condition>Barrett's Esophagus Without Dysplasia</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EsoCheck</intervention_name>
      <description>EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who have recently undergone or are scheduled to undergo EsoCheck administration&#xD;
          (as prescribed by a licensed healthcare provider) will be invited to participate in the&#xD;
          optional EsoGuard Registry.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males and Females who have provided informed consent for prospective registry&#xD;
               participation&#xD;
  &#xD;
            2. Subject in whom the clinical decision has been made to screen for BE/EAC using&#xD;
               EsoGuard testing on samples collected with EsoCheck&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to provide written informed consent&#xD;
  &#xD;
            2. Subjects who fall outside the eligible population defined by the EsoCheck device&#xD;
               Instructions For Use (IFU)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</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>LUCID DX</name>
        <address>
          <city>Lake Forest</city>
          <state>California</state>
          <zip>92630</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tiffany To</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Adenocarcinoma</mesh_term>
      <mesh_term>Barrett Esophagus</mesh_term>
      <mesh_term>Esophageal Neoplasms</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/NCT05965999
  org study id: LUD-PR-0421
  nct id: NCT05965999
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a multicenter, prospective, observational study designed to capture a limited set of
        data consisting of diagnostic test results and clinical management information on subjects
        who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for
        EsoGuard results to be available, as well as for any subsequent clinical evaluation to have
        been performed (e.g., upper endoscopy and any initial therapeutic management), study staff
        will obtain the desired information and record it in an electronic data collection (EDC)
        system, pertaining to subject demographics, pertinent medical history, and risk factors for
        BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient
        tolerance, (2) EsoGuard test result; (3) initial clinical management including upper
        endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist
        assessing any biopsies taken), as well as (4) additional clinical management and/or a
        therapeutic procedure(s) performed. The time point for collecting such information shall be
        fluid, depending on the time course of care provided subsequent to the EsoGuard result being
        available. It is expected typically to be approximately 4 months given the systemic delays in
        scheduling and performing upper endoscopies and obtaining biopsy results. There is no a
        priori limit on the timeline for obtaining these data, but it is . anticipated that all data
        collection will be completed within 8 months of the availability of EsoGuard results.
  observational model: Cohort
  time perspective: Prospective
  measure: Agreement between positive EsoGuard test results and upper endoscopy diagnosis (i.e., subjects with BE/EAC newly diagnosed by upper endoscopy)
  time frame: Through study completion, an average of 1 year
  measure: The number of subjects with a positive EsoGuard test
  time frame: Through study completion, an average of 1 year
  measure: Agreement between negative EsoGuard test results and upper endoscopy diagnosis (i.e., subjects determined not to have BE/EAC on upper endoscopy)
  time frame: Through study completion, an average of 1 year
  intervention type: Device
  intervention name: EsoCheck
  description: EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  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: 
  country: United States
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Barrett Esophagus
  mesh term: Esophageal Neoplasms
  sharing ipd: No