<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/NCT03270670</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00082253</org_study_id>
    <nct_id>NCT03270670</nct_id>
  </id_info>
  <brief_title>Olympus - 19-gauge Needle</brief_title>
  <official_title>A Pilot Study Evaluating the Performance of 19-gauge Needles in Testing Molecular Markers in Samples Obtained Via Endobronchial Ultrasound Guided Needle Aspiration of Lymph Nodes in Patients With Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      The purpose of this study is to test whether the 19-gauge needle can collect more tissue and&#xD;
      get better sampling during a bronchoscopy procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Molecular marker test</measure>
    <time_frame>Day of Procedure</time_frame>
    <description>Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects undergoing a standard of care bronchoscopy to determine lung cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by&#xD;
             a mediastinal lymph node &gt;0.5 cm in short axis on EBUS or any lymph node with uptake&#xD;
             on FDG-PET scan that is higher than background PET activity.&#xD;
&#xD;
          -  Participants must lack bleeding disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who lack fitness for flexible bronchoscopy as determined by the physician&#xD;
             performing the bronchoscopy before the procedure&#xD;
&#xD;
          -  Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites&#xD;
             (i.e. those without a known or suspected lung primary)&#xD;
&#xD;
          -  Subjects on anticoagulation (other than Aspirin) whom cannot have their&#xD;
             anticoagulation held for the procedure due to other clinical reasons (i.e. recent&#xD;
             cardiac stent placement).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Momen Wahidi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 6, 2019</last_update_submitted>
  <last_update_submitted_qc>September 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</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>Lung 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>


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/NCT03270670
org study id: Pro00082253
nct id: NCT03270670
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test whether the 19-gauge needle can collect more tissue and
      get better sampling during a bronchoscopy procedure.
observational model: Case-Only
time perspective: Prospective
measure: Molecular marker test
time frame: Day of Procedure
description: Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Momen Wahidi, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No