<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/NCT03802266</url>
  </required_header>
  <id_info>
    <org_study_id>Chest 010</org_study_id>
    <nct_id>NCT03802266</nct_id>
  </id_info>
  <brief_title>Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer</brief_title>
  <official_title>Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Chest 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>
      The purpose of this study is to compare Electromagnetic navigation guided with CT-guided&#xD;
      transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.&#xD;
&#xD;
      Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study&#xD;
      design: Multicenter、randomized、open lebel&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</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>Diagnostic rate</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operating time</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">322</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Electromagnetic Navigation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electromagnetic Navigation Guided Transthoracic Needle Aspiration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CT-guided Transthoracic Needle Aspiration</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic Navigation guided transthoracic needle aspiration</intervention_name>
    <description>Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule</description>
    <arm_group_label>Electromagnetic Navigation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT-guided Transthoracic Needle Aspiration</intervention_name>
    <description>Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule</description>
    <arm_group_label>CT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for&#xD;
             pathological diagnosis;&#xD;
&#xD;
          2. Patients who are older than 18 year-old;&#xD;
&#xD;
          3. Patients voluntarily join the study and give written informed consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.&#xD;
&#xD;
          2. Large blood vessels or important structures on the puncture path of peripheral lung&#xD;
             tumors；&#xD;
&#xD;
          3. Severe cardiopulmonary dysfunction and other indications that can't receive&#xD;
             bronchoscopy.&#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>Hua Zhong, Phd，MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hua Zhong, Phd，MD</last_name>
    <phone>13818200560</phone>
    <email>eddiedong8@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Chest hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Zhong, MD,PhD</last_name>
      <phone>86-21-22200000</phone>
      <phone_ext>3902</phone_ext>
      <email>eddiedong8@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Shuhui Cao, MD</last_name>
      <phone>86-21-22200000</phone>
      <phone_ext>3909</phone_ext>
      <email>caosh1994@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 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>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Hua Zhong</investigator_full_name>
    <investigator_title>Professor Hua Zhong</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03802266
org study id: Chest 010
nct id: NCT03802266
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided
      transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.

      Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study
      design: Multicenter、randomized、open lebel
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic rate
time frame: 18 months
measure: Operating time
time frame: 18 months
measure: Adverse events
time frame: 18 months
arm group label: Electromagnetic Navigation group
arm group type: Experimental
description: Electromagnetic Navigation Guided Transthoracic Needle Aspiration
arm group label: CT group
arm group type: Active Comparator
description: CT-guided Transthoracic Needle Aspiration
intervention type: Device
intervention name: Electromagnetic Navigation guided transthoracic needle aspiration
description: Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
arm group label: Electromagnetic Navigation group
intervention type: Device
intervention name: CT-guided Transthoracic Needle Aspiration
description: Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
arm group label: CT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hua Zhong, Phd，MD
role: Principal Investigator
affiliation: Shanghai Chest Hospital
last name: Hua Zhong, Phd，MD
phone: 13818200560
email: eddiedong8@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Hua Zhong
investigator title: Professor Hua Zhong
mesh term: Lung Neoplasms