<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/NCT04447482</url>
  </required_header>
  <id_info>
    <org_study_id>202001131102-CT</org_study_id>
    <nct_id>NCT04447482</nct_id>
  </id_info>
  <brief_title>ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions</brief_title>
  <official_title>A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Youhe Medical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Youhe Medical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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>
      Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic&#xD;
      Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for&#xD;
      diagnostic biopsy and detection of lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this clinical trial is to evaluate the safety and efficacy results for two&#xD;
      bronchoscopic biopsy techniques for sampling lung lesions: either image-guided&#xD;
      electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic&#xD;
      yield and adverse events of participants prospectively randomized to either arm will be&#xD;
      evaluated. This is a prospective, randomized, multi-center study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.</measure>
    <time_frame>6 months.</time_frame>
    <description>Diagnostic rate is defined as the proportion of true positive and true negative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sampling success rate of the treatment group and the control group.</measure>
    <time_frame>2 weeks.</time_frame>
    <description>Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigation time (time to find the lesions) of the treatment group and the control group.</measure>
    <time_frame>Duration of procedure, or up to 120 minutes.</time_frame>
    <description>For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to the biopsy tool reaching the lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total operation time of the treatment group and the control group.</measure>
    <time_frame>Duration of procedure, or up to 120 minutes.</time_frame>
    <description>For this outcome, duration of procedure is defined as the time from the bronchoscopy accessing the glottis for the first time to bronchoscopy exiting the glottis for the last time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigation success rate of 4D-ENB and biopsy accessories.</measure>
    <time_frame>Duration of procedure, or up to 120 minutes.</time_frame>
    <description>Navigation success rate is defined as the proportion of the biopsy tools reaching the lung tissues. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.</measure>
    <time_frame>Duration of procedure, or up to 120 minutes.</time_frame>
    <description>Device performance means the functions, reliability, safety and accessibility of the system. Performance will be evaluated by observing these characteristics during the procedure. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">212</enrollment>
  <condition>Lung Neoplasms</condition>
  <condition>Pulmonary Neoplasm</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ENB with image-guided lung biopsy</intervention_name>
    <description>Electromagnetic navigational bronchoscopy system with tip tracked instruments.</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>SPiN Thoracic Navigation System™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Bronchoscopy guided by Fluoroscopy</intervention_name>
    <description>Bronchoscopic lung biopsy with fluoroscopy.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following criteria to be selected:&#xD;
&#xD;
               1. Be older than 18 (including 18) and younger than 75 (including 75);&#xD;
&#xD;
               2. The population with peripheral lung lesions detected in chest CT scanning and who&#xD;
                  require biopsy;&#xD;
&#xD;
               3. The subjects are willing to undergo bronchoscopy and meet the requirements for&#xD;
                  bronchoscopy;&#xD;
&#xD;
               4. The subjects or their guardians can understand the trial objective, volunteer to&#xD;
                  participate and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded if they meet any of the following criteria:&#xD;
&#xD;
               1. The patient is participating in another drug or medical device clinical trial&#xD;
                  (drug clinical trial within 3 months or medical device clinical trial within 1&#xD;
                  month);&#xD;
&#xD;
               2. Women of childbearing age who have positive pregnancy test result and lactating&#xD;
                  women;&#xD;
&#xD;
               3. Allergic to anesthetics;&#xD;
&#xD;
               4. Bronchoscopy contraindications, including: active massive hemoptysis; recent&#xD;
                  myocardial infarction or unstable angina pectoris; severe heart and lung&#xD;
                  dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency&#xD;
                  (such as severe coagulation disorders, uremia and severe pulmonary hypertension);&#xD;
                  severe superior vena cava obstruction syndrome; suspected aortic aneurysm;&#xD;
                  multiple pulmonary bullae; systemically extreme exhaustion.&#xD;
&#xD;
               5. Visible intraluminal lesions found during bronchoscopy;&#xD;
&#xD;
               6. Patients with severe lung diseases (including: severe bronchodilatation, severe&#xD;
                  emphysema, etc.) and patients determined to be unsuitable for the examination by&#xD;
                  the investigators;&#xD;
&#xD;
               7. Patients with a pacemaker or defibrillator;&#xD;
&#xD;
               8. Patients who cannot cooperate with the doctor to complete bronchoscopy, such as&#xD;
                  patients with mental and neurological diseases, mental retardation and mental&#xD;
                  disorders;&#xD;
&#xD;
               9. Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to&#xD;
                  diagnose the lesions, or other patients determined to be unsuitable for this&#xD;
                  trial by the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cathaly Hong</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Youhe Medical Technology Co., Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cathaly Hong</last_name>
    <phone>8613524168379</phone>
    <email>cathaly_hong@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hu Jian, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hu Jian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bai Chong, MD</last_name>
    </contact>
    <investigator>
      <last_name>Bai Chong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sun Jiayuan, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sun Jiayuan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Qiang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Li Qiang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Raval AA, Amir L. Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping. Lung Cancer Manag. 2016 Apr;5(1):9-19. doi: 10.2217/lmt-2015-0007. Epub 2016 Apr 8.</citation>
    <PMID>30643545</PMID>
  </reference>
  <reference>
    <citation>Flenaugh, E.L., &amp; Mohammed, K.H.. Initial Experience Using 4D Electromagnetic Navigation Bronchoscopy System With Tip Tracked Instruments For Localization of Peripheral Lung Nodules. The Internet Journal of Pulmonary Medicine 18(1): 1-7, 2016.</citation>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral Pulmonary Lesion</keyword>
  <keyword>Lung Biopsy</keyword>
  <keyword>Electromagnetic Navigation Bronchoscopy</keyword>
  <keyword>Bronchoscopy</keyword>
  <keyword>Fluoroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <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/NCT04447482
org study id: 202001131102-CT
nct id: NCT04447482
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic
      Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for
      diagnostic biopsy and detection of lung cancer.
The objective of this clinical trial is to evaluate the safety and efficacy results for two
      bronchoscopic biopsy techniques for sampling lung lesions: either image-guided
      electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic
      yield and adverse events of participants prospectively randomized to either arm will be
      evaluated. This is a prospective, randomized, multi-center study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
time frame: 6 months.
description: Diagnostic rate is defined as the proportion of true positive and true negative.
measure: Sampling success rate of the treatment group and the control group.
time frame: 2 weeks.
description: Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.
measure: Navigation time (time to find the lesions) of the treatment group and the control group.
time frame: Duration of procedure, or up to 120 minutes.
description: For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to the biopsy tool reaching the lesion.
measure: Total operation time of the treatment group and the control group.
time frame: Duration of procedure, or up to 120 minutes.
description: For this outcome, duration of procedure is defined as the time from the bronchoscopy accessing the glottis for the first time to bronchoscopy exiting the glottis for the last time.
measure: Navigation success rate of 4D-ENB and biopsy accessories.
time frame: Duration of procedure, or up to 120 minutes.
description: Navigation success rate is defined as the proportion of the biopsy tools reaching the lung tissues. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.
measure: Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.
time frame: Duration of procedure, or up to 120 minutes.
description: Device performance means the functions, reliability, safety and accessibility of the system. Performance will be evaluated by observing these characteristics during the procedure. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.
arm group label: Treatment Group
arm group type: Experimental
description: 4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
arm group label: Control Group
arm group type: Active Comparator
description: Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.
intervention type: Device
intervention name: ENB with image-guided lung biopsy
description: Electromagnetic navigational bronchoscopy system with tip tracked instruments.
arm group label: Treatment Group
other name: SPiN Thoracic Navigation System™
intervention type: Procedure
intervention name: Conventional Bronchoscopy guided by Fluoroscopy
description: Bronchoscopic lung biopsy with fluoroscopy.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Cathaly Hong
role: Study Director
affiliation: Shanghai Youhe Medical Technology Co., Ltd.
last name: Cathaly Hong
phone: 8613524168379
email: cathaly_hong@163.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Raval AA, Amir L. Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping. Lung Cancer Manag. 2016 Apr;5(1):9-19. doi: 10.2217/lmt-2015-0007. Epub 2016 Apr 8.
PMID: 30643545
citation: Flenaugh, E.L., & Mohammed, K.H.. Initial Experience Using 4D Electromagnetic Navigation Bronchoscopy System With Tip Tracked Instruments For Localization of Peripheral Lung Nodules. The Internet Journal of Pulmonary Medicine 18(1): 1-7, 2016.
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lung Neoplasms