<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/NCT04486560</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00235679</org_study_id>
    <nct_id>NCT04486560</nct_id>
  </id_info>
  <brief_title>Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique</brief_title>
  <acronym>FROSTBITE</acronym>
  <official_title>Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erbe USA Incorporated</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and collect data on the initial&#xD;
      effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for&#xD;
      transbronchial lung biopsy via a bronchoscopic approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that&#xD;
      can be used for transbronchial biopsies. This device has the potential to gather larger and&#xD;
      higher quality tissue samples than the standard method using forceps, and with potentially&#xD;
      fewer complications than older, larger versions of the cryoprobe.&#xD;
&#xD;
      This study does not involve randomization or assigning different patients to different&#xD;
      procedures to compare. Everyone who enrolls in this study will undergo a standard of care&#xD;
      bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only&#xD;
      difference from the standard of care approach is that the physician performing the&#xD;
      transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another&#xD;
      currently available larger cryoprobe.&#xD;
&#xD;
      Patients enrolled in this study will have data collected by research staff for up to 30 days&#xD;
      after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the&#xD;
      standard of care following bronchoscopic biopsy procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">November 29, 2021</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>
    <intervention_model_description>This is a multi-center, non-randomized, single-arm, prospective trial. Therefore, all participants will have their transbronchial biopsy with the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events</measure>
    <time_frame>Within 30 days of procedure</time_frame>
    <description>The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Minor Adverse Events</measure>
    <time_frame>Within 30 days of procedure</time_frame>
    <description>The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Histologic Accessibility Grade</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Grade 0: Does not contain alveolar structures and can therefore not be assessed&#xD;
Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features&#xD;
Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible&#xD;
Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible&#xD;
Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible&#xD;
Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible&#xD;
Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis</measure>
    <time_frame>During procedure, up to 1 hour</time_frame>
    <description>Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Histologic Area (Square Millimeters)</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Amount of total histologic tissue in square millimeters observed under microscope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolated Area (Square Millimeters)</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Total amount of area in square millimeters containing alveoli.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open Alveoli Percent</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Percentage of all alveoli that are open.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Crush Artifact</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Artifact Free Lung Parenchyma Percent</measure>
    <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
    <description>Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activation Time (Seconds)</measure>
    <time_frame>At the time of procedure, up to 1 hour</time_frame>
    <description>Time of activation of cryoprobe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>At the time of procedure, up to 1 hour</time_frame>
    <description>Time for entire procedure measured in minutes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Single Arm: Cryoprobe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651</intervention_name>
    <description>ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
    <arm_group_label>Single Arm: Cryoprobe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, ≥ 18-years-old&#xD;
&#xD;
          -  Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical&#xD;
             care determined by their treating pulmonologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing females, or females of child bearing potential who refuse to take&#xD;
             a pregnancy test prior to enrollment&#xD;
&#xD;
          -  Individuals with current or recent systematic conditions, such as uncontrolled&#xD;
             hypertension (systolic &gt; 200 mmHg or diastolic &gt; 110 mmHg), type 1 diabetes, severe&#xD;
             pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or&#xD;
             myocardial infarction (within the last 3 months)&#xD;
&#xD;
          -  Presence of bleeding disorder&#xD;
&#xD;
          -  Platelet count &lt;50,000&#xD;
&#xD;
          -  Current use of systemic anticoagulation or antiplatelet therapy without the ability to&#xD;
             hold therapy for the recommended amount of time prior to an invasive procedure&#xD;
             (aspirin monotherapy is acceptable)&#xD;
&#xD;
          -  International Normalized Ratio (INR) &lt;1.5&#xD;
&#xD;
          -  Robotic 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>Lonny Yarmus</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <results_first_submitted>January 7, 2022</results_first_submitted>
  <results_first_submitted_qc>February 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 11, 2022</results_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung</keyword>
  <keyword>cryoprobe</keyword>
  <keyword>bronchoscopic</keyword>
  <keyword>biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT04486560/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm: Cryoprobe</title>
          <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm: Cryoprobe</title>
          <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indication for Biopsy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pulmonary Parenchymal Lesion</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Diffuse Lung Disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lung Transplant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Airway</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Laryngeal Mask Airway</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Endotracheal Tube</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rigid Bronchoscopy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bronchial Blocker Used</title>
          <description>Participants in whom bronchial blocker was used.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of Biopsy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Right Upper Lobe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right Middle Lobe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right Lower Lobe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left Upper Lobe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left Lower Lobe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events</title>
        <description>The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.</description>
        <time_frame>Within 30 days of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events</title>
          <description>The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Minor Adverse Events</title>
        <description>The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).</description>
        <time_frame>Within 30 days of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Minor Adverse Events</title>
          <description>The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1 Pneumothorax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1-2 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Histologic Accessibility Grade</title>
        <description>Grade 0: Does not contain alveolar structures and can therefore not be assessed&#xD;
Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features&#xD;
Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible&#xD;
Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible&#xD;
Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible&#xD;
Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible&#xD;
Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Histologic Accessibility Grade</title>
          <description>Grade 0: Does not contain alveolar structures and can therefore not be assessed&#xD;
Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features&#xD;
Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible&#xD;
Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible&#xD;
Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible&#xD;
Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible&#xD;
Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis</title>
        <description>Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.</description>
        <time_frame>During procedure, up to 1 hour</time_frame>
        <population>The analysis was broken down by type of cryobiopsy indication.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis</title>
          <description>Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.</description>
          <population>The analysis was broken down by type of cryobiopsy indication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lung Transplant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diffuse Lung Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulmonary Parenchymal Lesion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Histologic Area (Square Millimeters)</title>
        <description>Amount of total histologic tissue in square millimeters observed under microscope.</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Total Histologic Area (Square Millimeters)</title>
          <description>Amount of total histologic tissue in square millimeters observed under microscope.</description>
          <units>square millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4" lower_limit="21.1" upper_limit="87.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alveolated Area (Square Millimeters)</title>
        <description>Total amount of area in square millimeters containing alveoli.</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Alveolated Area (Square Millimeters)</title>
          <description>Total amount of area in square millimeters containing alveoli.</description>
          <units>square millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of Pieces</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of Pieces</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Per Patient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.39" lower_limit="0" upper_limit="51.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Per Piece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" lower_limit="0" upper_limit="18.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Open Alveoli Percent</title>
        <description>Percentage of all alveoli that are open.</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Open Alveoli Percent</title>
          <description>Percentage of all alveoli that are open.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of Samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of Samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.48" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Crush Artifact</title>
        <description>Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Crush Artifact</title>
          <description>Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Artifact Free Lung Parenchyma Percent</title>
        <description>Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.</description>
        <time_frame>Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Artifact Free Lung Parenchyma Percent</title>
          <description>Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Number of Samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of Samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.86" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activation Time (Seconds)</title>
        <description>Time of activation of cryoprobe.</description>
        <time_frame>At the time of procedure, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Activation Time (Seconds)</title>
          <description>Time of activation of cryoprobe.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="3.2" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Time</title>
        <description>Time for entire procedure measured in minutes.</description>
        <time_frame>At the time of procedure, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm: Cryoprobe</title>
            <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Time</title>
          <description>Time for entire procedure measured in minutes.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="10" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day of procedure through 30 days post-procedure</time_frame>
      <desc>Primary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade ≥ 3, pneumothorax grade ≥ 2, post-procedure respiratory failure, and/or death related to the device.&#xD;
Secondary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade &lt; 3 and/or pneumothorax grade &lt; 2 related to the device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Single Arm: Cryoprobe</title>
          <description>Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.&#xD;
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>SECONDARY SAFETY ENDPOINT Adverse Event</sub_title>
                <description>Occurrence of bleeding grade &lt; 3 and/or pneumothorax grade &lt; 2 related to the device</description>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All procedures were performed at large academic centers so procedural volume and pathology may not be generalizable. Larger proportion of lung transplant patients enrolled means there is a lack of heterogeneity in disease entities. Study aimed to address safety so the design and sample size is too small to accurately estimate diagnostic yield. Sheath was required for all cases, precluding use of robotic-assisted bronchoscopy (and underrepresentation of lung cancer).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Lonny Yarmus</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-502-5224</phone>
      <email>lyarmus@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04486560
org study id: IRB00235679
nct id: NCT04486560
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the safety and collect data on the initial
      effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for
      transbronchial lung biopsy via a bronchoscopic approach.
A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that
      can be used for transbronchial biopsies. This device has the potential to gather larger and
      higher quality tissue samples than the standard method using forceps, and with potentially
      fewer complications than older, larger versions of the cryoprobe.

      This study does not involve randomization or assigning different patients to different
      procedures to compare. Everyone who enrolls in this study will undergo a standard of care
      bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only
      difference from the standard of care approach is that the physician performing the
      transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another
      currently available larger cryoprobe.

      Patients enrolled in this study will have data collected by research staff for up to 30 days
      after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the
      standard of care following bronchoscopic biopsy procedures.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a multi-center, non-randomized, single-arm, prospective trial. Therefore, all participants will have their transbronchial biopsy with the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With Serious Adverse Events
time frame: Within 30 days of procedure
description: The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.
measure: Number of Participants With Minor Adverse Events
time frame: Within 30 days of procedure
description: The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).
measure: Mean Histologic Accessibility Grade
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Grade 0: Does not contain alveolar structures and can therefore not be assessed
Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features
Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible
Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible
Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible
Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible
Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features
measure: Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis
time frame: During procedure, up to 1 hour
description: Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.
measure: Total Histologic Area (Square Millimeters)
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Amount of total histologic tissue in square millimeters observed under microscope.
measure: Alveolated Area (Square Millimeters)
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Total amount of area in square millimeters containing alveoli.
measure: Open Alveoli Percent
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Percentage of all alveoli that are open.
measure: Percent Crush Artifact
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.
measure: Artifact Free Lung Parenchyma Percent
time frame: Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
description: Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.
measure: Activation Time (Seconds)
time frame: At the time of procedure, up to 1 hour
description: Time of activation of cryoprobe.
measure: Procedure Time
time frame: At the time of procedure, up to 1 hour
description: Time for entire procedure measured in minutes.
arm group label: Single Arm: Cryoprobe
arm group type: Experimental
description: Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.
intervention type: Device
intervention name: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
description: ERBE 1.1mm flexible single-use cryoprobe with oversheath
arm group label: Single Arm: Cryoprobe
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lonny Yarmus
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All procedures were performed at large academic centers so procedural volume and pathology may not be generalizable. Larger proportion of lung transplant patients enrolled means there is a lack of heterogeneity in disease entities. Study aimed to address safety so the design and sample size is too small to accurately estimate diagnostic yield. Sheath was required for all cases, precluding use of robotic-assisted bronchoscopy (and underrepresentation of lung cancer).
point of contact: 