<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/NCT04471324</url>
  </required_header>
  <id_info>
    <org_study_id>Cryo SPN 1.1 trial</org_study_id>
    <nct_id>NCT04471324</nct_id>
  </id_info>
  <brief_title>EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study</brief_title>
  <official_title>EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thoraxklinik-Heidelberg gGmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erbe Elektromedizin GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Thoraxklinik-Heidelberg gGmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with&#xD;
      transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray&#xD;
      fluoroscopy, the diagnostic value of this method depends strongly on the size, location and&#xD;
      relationship of the foci to the airways as well as their radiological representability. By&#xD;
      inserting radial 20 MHz ultrasound probes through the working channel of a flexible&#xD;
      bronchoscope into the periphery of the lung, the detection of peripheral foci can be&#xD;
      improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope,&#xD;
      even smaller round foci in the periphery of the lung can be detected. For some years now,&#xD;
      tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in&#xD;
      lesions that can only be reached endoscopically tangentially, advantages have been shown over&#xD;
      forceps biopsy. Much larger tissue samples can be obtained without increasing the&#xD;
      complication rate. Studies showed that the combination of the EBUS navigation technique with&#xD;
      the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung&#xD;
      tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe&#xD;
      with an ultra-thin bronchoscope together with the radial EBUS can further improve the&#xD;
      diagnosis. This study is a non-randomized pilot study to prove the feasibility of this&#xD;
      procedure. The EBUS probe and the bronchoscope are CE certified for this application. The&#xD;
      study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University&#xD;
      Hospital.&#xD;
&#xD;
      A total of 30 patients with an indication for transbronchial biopsy will be prospectively&#xD;
      included. All patients will be examined according to the clinical standard. After a freezing&#xD;
      time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the&#xD;
      sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken&#xD;
      depending on the investigator's assessment. The samples will be collected separately and the&#xD;
      order of the biopsies will be recorded. The primary endpoint is the feasibility of the&#xD;
      procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and&#xD;
      success rate depending on the position of the EBUS probe (tangential or central).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion</measure>
    <time_frame>Day 1</time_frame>
    <description>Pathological assessment of biopsies for ILD diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding time in seconds</measure>
    <time_frame>Day 1 until Day 2</time_frame>
    <description>Assessed by using a stop watch and entering data into a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of biopsies</measure>
    <time_frame>Day 1</time_frame>
    <description>Planimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of biopsies</measure>
    <time_frame>Day 1</time_frame>
    <description>artefact-free biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exacerbation rate</measure>
    <time_frame>4 weeks after biopsy</time_frame>
    <description>Assessment of exacerbations until 4 weeks after biopsy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Transbronchial Cryobiopsy</condition>
  <arm_group>
    <arm_group_label>EBUS cryo probe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a transbronchial cryobiopsy using an eBUS cryo probe</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EBUS cryo probe</intervention_name>
    <description>patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope</description>
    <arm_group_label>EBUS cryo probe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single or multiple peripheral pulmonary round foci in CT&#xD;
&#xD;
          -  signed patient information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe co-mornidity&#xD;
&#xD;
          -  no signed patien information&#xD;
&#xD;
          -  contraindication for intervention&#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>Ralf Eberhardt, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thoraxklinik Universitaetsklinikum Heidelberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thoraxklinik Universitaetsmedizin</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>October 9, 2020</last_update_submitted>
  <last_update_submitted_qc>October 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04471324
org study id: Cryo SPN 1.1 trial
nct id: NCT04471324
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with
      transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray
      fluoroscopy, the diagnostic value of this method depends strongly on the size, location and
      relationship of the foci to the airways as well as their radiological representability. By
      inserting radial 20 MHz ultrasound probes through the working channel of a flexible
      bronchoscope into the periphery of the lung, the detection of peripheral foci can be
      improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope,
      even smaller round foci in the periphery of the lung can be detected. For some years now,
      tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in
      lesions that can only be reached endoscopically tangentially, advantages have been shown over
      forceps biopsy. Much larger tissue samples can be obtained without increasing the
      complication rate. Studies showed that the combination of the EBUS navigation technique with
      the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung
      tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe
      with an ultra-thin bronchoscope together with the radial EBUS can further improve the
      diagnosis. This study is a non-randomized pilot study to prove the feasibility of this
      procedure. The EBUS probe and the bronchoscope are CE certified for this application. The
      study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University
      Hospital.

      A total of 30 patients with an indication for transbronchial biopsy will be prospectively
      included. All patients will be examined according to the clinical standard. After a freezing
      time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the
      sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken
      depending on the investigator's assessment. The samples will be collected separately and the
      order of the biopsies will be recorded. The primary endpoint is the feasibility of the
      procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and
      success rate depending on the position of the EBUS probe (tangential or central).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion
time frame: Day 1
description: Pathological assessment of biopsies for ILD diagnosis
measure: Bleeding time in seconds
time frame: Day 1 until Day 2
description: Assessed by using a stop watch and entering data into a questionnaire
measure: Size of biopsies
time frame: Day 1
description: Planimetry
measure: Quality of biopsies
time frame: Day 1
description: artefact-free biopsies
measure: Exacerbation rate
time frame: 4 weeks after biopsy
description: Assessment of exacerbations until 4 weeks after biopsy
arm group label: EBUS cryo probe
arm group type: Experimental
description: Patients receive a transbronchial cryobiopsy using an eBUS cryo probe
intervention type: Device
intervention name: EBUS cryo probe
description: patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope
arm group label: EBUS cryo probe
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ralf Eberhardt, Prof. Dr. med.
role: Principal Investigator
affiliation: Thoraxklinik Universitaetsklinikum Heidelberg
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Multiple Pulmonary Nodules
sharing ipd: No