<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/NCT03272971</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol 45</org_study_id>
    <nct_id>NCT03272971</nct_id>
  </id_info>
  <brief_title>Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors</brief_title>
  <official_title>Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Broncus Medical Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uptake Medical Technology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Broncus Medical Inc</source>
  <oversight_info>
    <has_dmc>No</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>
      The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be&#xD;
      evaluated in patients already scheduled for surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single-arm, single-center, pilot study of bronchoscopic&#xD;
      Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor&#xD;
      resection. Up to ten (10) subjects will be treated at the investigational site.&#xD;
&#xD;
      Subjects identified for this study will be those that have a surgical resection already&#xD;
      scheduled as part of their lung cancer treatment. Patients who have consented to participate&#xD;
      in this study (enrolled) will undergo screening assessments to evaluate the inclusion&#xD;
      criteria associated with their lung cancer and general health. Only patients that meet all of&#xD;
      the inclusion criteria and none of the exclusion criteria will be scheduled for RFA&#xD;
      treatment.&#xD;
&#xD;
      Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize&#xD;
      the lesion and determine the access pathways for ablation. At the time of the RFA procedure,&#xD;
      a point-of-entry, along a bronchial wall, is created under an image-guided navigation system.&#xD;
      The RFA catheter is advanced down the access path until it reaches the tumor and RF is&#xD;
      administered at the prescribed dose. Upon completion of the RFA treatment, the subject is&#xD;
      immediately prepared for surgical resection in accordance with their lung cancer standard of&#xD;
      care. There are no follow-up visits as part of this study, the subject is excited following&#xD;
      surgical resection.&#xD;
&#xD;
      The resected tissue will undergo pathological evaluation for tissue viability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RFA relate AEs/SAEs</measure>
    <time_frame>Day 0</time_frame>
    <description>The incidence of reported adverse events and serious adverse events related to the RFA procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Ablated Tissue</measure>
    <time_frame>Day 0</time_frame>
    <description>Semi-quantitative scoring of necrotic tissue assessed by histology</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Delivery of Ablation</measure>
    <time_frame>Day 0</time_frame>
    <description>Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Lung Cancer Metastatic</condition>
  <condition>Lung Cancer, Non-small Cell</condition>
  <arm_group>
    <arm_group_label>Radio-frequency Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radio-frequency Ablation</intervention_name>
    <description>The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.</description>
    <arm_group_label>Radio-frequency Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor&#xD;
&#xD;
          -  Must be eligible for curative lung resection (lobectomy)&#xD;
&#xD;
          -  Tumor/lesion size will be a minimum of 10mm along the minor diameter&#xD;
&#xD;
          -  Willing to participate in all aspects of study protocol for duration of the study&#xD;
&#xD;
          -  Able to understand study requirements&#xD;
&#xD;
          -  Signs informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to bronchoscopy, for example:&#xD;
&#xD;
               -  Untreatable life-threatening arrhythmias.&#xD;
&#xD;
               -  Inability to adequately oxygenate the patient during the procedure.&#xD;
&#xD;
               -  Acute respiratory failure with hypercapnia (unless the patient is intubated and&#xD;
                  ventilated).&#xD;
&#xD;
               -  Recent myocardial infarction.&#xD;
&#xD;
               -  Previously diagnosed high-grade tracheal obstruction.&#xD;
&#xD;
               -  Uncorrectable coagulopathy&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
          -  Platelet dysfunction or platelet count &lt;100 x 10^3 cells/mm3&#xD;
&#xD;
          -  History of major bleeding with bronchoscopy&#xD;
&#xD;
          -  Suspected pulmonary hypertension: additional testing required, such as ECG&#xD;
&#xD;
          -  Moderate-to-severe pulmonary fibrosis&#xD;
&#xD;
          -  Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD):&#xD;
&#xD;
        additional testing and PI consent is required&#xD;
&#xD;
          -  Bullae &gt;5cm located within the same lobe of target tumor/lesion&#xD;
&#xD;
          -  Any other severe or life-threatening comorbidity that could increase the risk&#xD;
             associated with bronchoscopic RFA&#xD;
&#xD;
          -  Ongoing systemic infection&#xD;
&#xD;
          -  Contraindications to general anesthesia&#xD;
&#xD;
          -  Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated&#xD;
             by the protocol&#xD;
&#xD;
          -  Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion&#xD;
&#xD;
          -  Breastfeeding women or females of childbearing potential with a positive pregnancy&#xD;
             test prior to the procedure or the intent to become pregnant during the study&#xD;
&#xD;
          -  Life expectancy of less than one year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>bronchoscopy</keyword>
  <keyword>NSCLC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT03272971
org study id: Protocol 45
nct id: NCT03272971
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be
      evaluated in patients already scheduled for surgical resection.
This study is a prospective, single-arm, single-center, pilot study of bronchoscopic
      Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor
      resection. Up to ten (10) subjects will be treated at the investigational site.

      Subjects identified for this study will be those that have a surgical resection already
      scheduled as part of their lung cancer treatment. Patients who have consented to participate
      in this study (enrolled) will undergo screening assessments to evaluate the inclusion
      criteria associated with their lung cancer and general health. Only patients that meet all of
      the inclusion criteria and none of the exclusion criteria will be scheduled for RFA
      treatment.

      Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize
      the lesion and determine the access pathways for ablation. At the time of the RFA procedure,
      a point-of-entry, along a bronchial wall, is created under an image-guided navigation system.
      The RFA catheter is advanced down the access path until it reaches the tumor and RF is
      administered at the prescribed dose. Upon completion of the RFA treatment, the subject is
      immediately prepared for surgical resection in accordance with their lung cancer standard of
      care. There are no follow-up visits as part of this study, the subject is excited following
      surgical resection.

      The resected tissue will undergo pathological evaluation for tissue viability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: RFA relate AEs/SAEs
time frame: Day 0
description: The incidence of reported adverse events and serious adverse events related to the RFA procedure
measure: Feasibility - Ablated Tissue
time frame: Day 0
description: Semi-quantitative scoring of necrotic tissue assessed by histology
measure: Feasibility - Delivery of Ablation
time frame: Day 0
description: Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.
arm group label: Radio-frequency Ablation
arm group type: Experimental
description: Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.
intervention type: Device
intervention name: Radio-frequency Ablation
description: The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.
arm group label: Radio-frequency Ablation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung