<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/NCT03802812</url>
  </required_header>
  <id_info>
    <org_study_id>TBVBN study</org_study_id>
    <secondary_id>2018R1C1B5085364</secondary_id>
    <nct_id>NCT03802812</nct_id>
  </id_info>
  <brief_title>Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis</brief_title>
  <official_title>Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Hospital</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>
      This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation&#xD;
      system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring&#xD;
      mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and&#xD;
      stain/culture conversion are also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between&#xD;
      patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided&#xD;
      thin bronchoscope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">April 19, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>detection of M. tuberculosis and resistant-conferring mutations</measure>
    <time_frame>2months after procedure</time_frame>
    <description>evaulation by sensitivity, specificity, PPV and NPV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to appropriate treatment and stain/culture conversion</measure>
    <time_frame>6months after procedure</time_frame>
    <description>date of treatment initiation and stain/culture negative conversion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Conventional arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Perform bronchial washing using conventional methods.&#xD;
CT-guided thick bronchoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Perform bronchial washing using investigational methods.&#xD;
virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thin bronchoscope and VBN</intervention_name>
    <description>targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system</description>
    <arm_group_label>Investigational arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18 or more&#xD;
&#xD;
          -  persons who are suspected with pulmonary tuberculosis on radiologic examination&#xD;
&#xD;
          -  persons who cannot spit sputum or persons with negative results on sputum AFB smear&#xD;
             and TB-PCR or Xpert MTB/RIF assay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons who do not agree with bronchoscopy (persons who want empirical treatment for&#xD;
             TB)&#xD;
&#xD;
          -  persons with contraindications for bronchoscopy&#xD;
&#xD;
               -  bleeding tendency&#xD;
&#xD;
               -  uncontrolled respiratory disease (hypoxemia)&#xD;
&#xD;
               -  uncontrolled cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeongha Mok, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeongha Mok</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03802812
org study id: TBVBN study
secondary id: 2018R1C1B5085364
nct id: NCT03802812
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation
      system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring
      mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and
      stain/culture conversion are also evaluated.
Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between
      patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided
      thin bronchoscope.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: detection of M. tuberculosis and resistant-conferring mutations
time frame: 2months after procedure
description: evaulation by sensitivity, specificity, PPV and NPV
measure: time to appropriate treatment and stain/culture conversion
time frame: 6months after procedure
description: date of treatment initiation and stain/culture negative conversion
arm group label: Conventional arm
arm group type: No Intervention
description: Perform bronchial washing using conventional methods.
CT-guided thick bronchoscope
arm group label: Investigational arm
arm group type: Active Comparator
description: Perform bronchial washing using investigational methods.
virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
intervention type: Device
intervention name: Thin bronchoscope and VBN
description: targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
arm group label: Investigational arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeongha Mok, MD, PhD
role: Principal Investigator
affiliation: Pusan National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Hospital
investigator full name: Jeongha Mok
investigator title: Clinical Professor
mesh term: Tuberculosis
sharing ipd: Undecided