<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/NCT02196974</url>
  </required_header>
  <id_info>
    <org_study_id>24185</org_study_id>
    <nct_id>NCT02196974</nct_id>
  </id_info>
  <brief_title>Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy</brief_title>
  <official_title>Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies&#xD;
      obtained with flexible cryoprobes compared to standard techniques? For patients with&#xD;
      peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue&#xD;
      to be obtained and therefore, will increase the diagnostic yield over conventional techniques&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incremental diagnostic yield of cryobiopsy over the standard specimens</measure>
    <time_frame>1 year after completion of recruitment</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Lung Nodules</condition>
  <arm_group>
    <arm_group_label>cryobiopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryobiopsy</intervention_name>
    <arm_group_label>cryobiopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Age &gt;18 years 2. Lung nodule (s) identified on CT scan 3. Clinical decision to&#xD;
             obtain tissue biopsy of lung lesion 4. CT guided biopsy not preferred technique&#xD;
&#xD;
               -  Previous negative CT guided biopsy&#xD;
&#xD;
               -  Technically difficult nodule location&#xD;
&#xD;
               -  Perceived high risk of pneumothorax or other complications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Lack of informed consent 2. Nodule less than 1 cm or greater than 6 cm long axis 3.&#xD;
             Significant mediastinal adenopathy. 4. No suspected sites of disease outside the&#xD;
             thorax amenable to biopsy 5. Evidence of endobronchial abnormality on chest CT 6.&#xD;
             Medical contraindication to bronchoscopy 7. Patients with lesions highly suspicious&#xD;
             for lung cancer, potentially resectable with lobar or lesser resection and without&#xD;
             significantly increased operative risk factors will not be entered into this study&#xD;
             prior to surgical evaluation.&#xD;
&#xD;
             8. Uncontrolled or irreversible coagulopathy&#xD;
&#xD;
               -  platelets &lt;100&#xD;
&#xD;
               -  INR &gt;1.3&#xD;
&#xD;
               -  Use of clopidogrel in the 7 days prior to bronchoscopy 9. Confirmed or suspected&#xD;
                  pregnancy 10. Clinically unable to tolerate a pneumothorax or single-lung&#xD;
                  ventilation 11. Pacemaker or implanted cardiac defibrillator if it is felt that&#xD;
                  ENB is needed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Paul MacEachern</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>bronchoscopy</keyword>
  <keyword>lung nodule</keyword>
  <keyword>diagnosis</keyword>
  <keyword>cryobiopsy</keyword>
  <!-- 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/NCT02196974
org study id: 24185
nct id: NCT02196974
lead sponsor: 
has dmc: No
In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies
      obtained with flexible cryoprobes compared to standard techniques? For patients with
      peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue
      to be obtained and therefore, will increase the diagnostic yield over conventional techniques
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: incremental diagnostic yield of cryobiopsy over the standard specimens
time frame: 1 year after completion of recruitment
arm group label: cryobiopsy
arm group type: Experimental
intervention type: Procedure
intervention name: cryobiopsy
arm group label: cryobiopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Paul MacEachern
investigator title: Clinical Assistant Professor