<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/NCT03793387</url>
  </required_header>
  <id_info>
    <org_study_id>107-097-F</org_study_id>
    <nct_id>NCT03793387</nct_id>
  </id_info>
  <brief_title>Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule</brief_title>
  <official_title>Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital Hsin-Chu Branch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital Hsin-Chu Branch</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing pre-operative transbronchial localization under augmented fluoroscopy and&#xD;
      intra-operative transbronchial localization using electromagnetic navigation bronchoscopy&#xD;
      system for small lung nodules.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be&#xD;
      performed in the operating room (OR) under general anesthesia without extra radiation&#xD;
      exposure, which is expected to reduce the discomfort for the patient during localization.&#xD;
      This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital.&#xD;
      It is expected that 40 patients with pulmonary nodules will be randomly assigned into two&#xD;
      groups. One group will receive bronchoscopic dye localization in the hybrid examination room&#xD;
      equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye&#xD;
      localization in OR. The primary goal of the study was to compare the localization duration of&#xD;
      the two groups of patients, the total dose of radiation exposure during localization and the&#xD;
      incidence of location-related complications, and the secondary goals were the results of the&#xD;
      surgical procedure, including the surgical duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful localization</measure>
    <time_frame>2 days</time_frame>
    <description>Discrepancy from lesion to marking: less than 1 cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful resection</measure>
    <time_frame>2 days</time_frame>
    <description>Lesion contained in first resected specimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Localization duration</measure>
    <time_frame>1 day</time_frame>
    <description>Total time span of localization procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total radiation exposure</measure>
    <time_frame>2 days</time_frame>
    <description>Radiation during entire localization procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>14 days</time_frame>
    <description>Procedure related complication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Pre-op</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intra-op</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AF-guided endobronchial marking</intervention_name>
    <description>Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance</description>
    <arm_group_label>Pre-op</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ENB-guided endobronchial marking</intervention_name>
    <description>Bronchoscopic dye marking with ENB system</description>
    <arm_group_label>Intra-op</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20~90&#xD;
        years old C. sign permit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding&#xD;
        tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F.&#xD;
        Immunocompromised G. Severe infection H. Unable to sign permit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shun-Mao Yang, MD</last_name>
    <phone>+886-972-654-475</phone>
    <email>mutayang@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital, Hsin-Chu Branch</name>
      <address>
        <city>Taipei</city>
        <state>Hsin-Chu County</state>
        <zip>30059</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chiu-kuei Nien</last_name>
      <phone>886-3-5326151</phone>
      <email>hch01215@hch.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03793387
org study id: 107-097-F
nct id: NCT03793387
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Comparing pre-operative transbronchial localization under augmented fluoroscopy and
      intra-operative transbronchial localization using electromagnetic navigation bronchoscopy
      system for small lung nodules.
Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be
      performed in the operating room (OR) under general anesthesia without extra radiation
      exposure, which is expected to reduce the discomfort for the patient during localization.
      This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital.
      It is expected that 40 patients with pulmonary nodules will be randomly assigned into two
      groups. One group will receive bronchoscopic dye localization in the hybrid examination room
      equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye
      localization in OR. The primary goal of the study was to compare the localization duration of
      the two groups of patients, the total dose of radiation exposure during localization and the
      incidence of location-related complications, and the secondary goals were the results of the
      surgical procedure, including the surgical duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful localization
time frame: 2 days
description: Discrepancy from lesion to marking: less than 1 cm
measure: Successful resection
time frame: 2 days
description: Lesion contained in first resected specimen
measure: Localization duration
time frame: 1 day
description: Total time span of localization procedure
measure: Total radiation exposure
time frame: 2 days
description: Radiation during entire localization procedure
measure: Complication
time frame: 14 days
description: Procedure related complication
arm group label: Pre-op
arm group type: Experimental
arm group label: Intra-op
arm group type: Active Comparator
intervention type: Procedure
intervention name: AF-guided endobronchial marking
description: Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
arm group label: Pre-op
intervention type: Device
intervention name: ENB-guided endobronchial marking
description: Bronchoscopic dye marking with ENB system
arm group label: Intra-op
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Shun-Mao Yang, MD
phone: +886-972-654-475
email: mutayang@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: Undecided