<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/NCT01682018</url>
  </required_header>
  <id_info>
    <org_study_id>RMC126908</org_study_id>
    <nct_id>NCT01682018</nct_id>
  </id_info>
  <brief_title>The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung</brief_title>
  <official_title>Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves&#xD;
      (Zephyr) would reduce native lung overinflation in patients that underwent single lung&#xD;
      transplantation due to emphysema, and improve their well being and pulmonary function tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emphysema is a progressive pulmonary disease characterized by abnormal and permanent&#xD;
      enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of&#xD;
      pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation&#xD;
      and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit&#xD;
      from surgical lung volume reduction and/or lung transplantation. The rationale for lung&#xD;
      volume reduction surgery is that reducing lung size would restore elastic recoil of the lung&#xD;
      and improve chest wall and diaphragm mechanics. It has previously been shown that&#xD;
      particularly patients with heterogeneous emphysema seem to benefit most from surgical lung&#xD;
      volume reduction.&#xD;
&#xD;
      Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive&#xD;
      potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects&#xD;
      of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively&#xD;
      occlude the airways supplying the most affected hyperinflated regions of the emphysematous&#xD;
      lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar&#xD;
      volume reduction, simulating the effects of surgical LVR.&#xD;
&#xD;
      The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves&#xD;
      (Zephyr) would reduce native lung overinflation in patients that underwent single lung&#xD;
      transplantation due to emphysema, and improve their well being and pulmonary function tests&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>•Mean % change in lung function (FEV1)</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in six minutes walk distance</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lung volume reduction using the Zephyr device</intervention_name>
    <description>lung volume reduction using the Zephyr device</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Single lung transplantation due to emphysema at least six months following transplantation&#xD;
        that developed native lung overinflation&#xD;
&#xD;
          -  Age from 40 to 75 years&#xD;
&#xD;
          -  BMI &lt; 32 kg/m2&#xD;
&#xD;
          -  FEV1 &lt; 40% of predicted value, FEV1/FVC &lt; 70%&#xD;
&#xD;
          -  TLC &gt; 120% predicted, RV &gt; 150% predicted.&#xD;
&#xD;
          -  Stable with &lt; 20 mg prednisone (or equivalent) qd&#xD;
&#xD;
          -  PaCO2 &lt; 50mm Hg&#xD;
&#xD;
          -  PaO2 &gt; 45 mm Hg on room air&#xD;
&#xD;
          -  6-min walk of &gt; 50m (without rehabilitation) or &gt; 100m (with rehabilitation)&#xD;
&#xD;
          -  Nonsmoking for 4 months prior to initial interview and throughout screening&#xD;
&#xD;
          -  The patient agrees to all protocol required follow-up intervals.&#xD;
&#xD;
          -  The patient has no child bearing potential&#xD;
&#xD;
          -  The patient is willing and able to complete protocol required baseline assessments and&#xD;
             procedures Exclusion criteria&#xD;
&#xD;
          -  Prior endobronchial treatment for emphysema&#xD;
&#xD;
          -  Pleural or interstitial disease that precludes surgery.&#xD;
&#xD;
          -  Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.&#xD;
&#xD;
          -  Clinically significant bronchiectasis&#xD;
&#xD;
          -  Pulmonary nodule requiring surgery&#xD;
&#xD;
          -  History of recurrent respiratory infections (&gt; 3 hospitalization in the last year)&#xD;
&#xD;
          -  Clinically significant (&gt; 4 Tablespoons per day) sputum production&#xD;
&#xD;
          -  Fever, elevated white cell count, or other evidence of active infection&#xD;
&#xD;
          -  Dysrhythmia that might pose a risk during exercise or training&#xD;
&#xD;
          -  Congestive heart failure within 6 mo and LVEF &lt; 45%&#xD;
&#xD;
          -  Evidence or history of Cor Pulmonale&#xD;
&#xD;
          -  Resting bradycardia (&lt; 50 beats/min), frequent multifocal PVCs, complex ventricular&#xD;
             arrhythmia, sustained SVT&#xD;
&#xD;
          -  History of exercise-related syncope&#xD;
&#xD;
          -  MI within 6 mo and LVEF &lt; 45%&#xD;
&#xD;
          -  Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr&#xD;
             period&#xD;
&#xD;
          -  Any disease or condition that interferes with completion of initial or follow-up&#xD;
             assessments&#xD;
&#xD;
          -  Patient is currently enrolled in another clinical trial&#xD;
&#xD;
          -  Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer&#xD;
&#xD;
          -  Alpha-1-Antitrypsin Deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mordechai Kramer Kramer, MD</last_name>
    <phone>97239377140</phone>
    <email>Kremerm@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>92100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Mordechai R Kramer, MD</last_name>
      <phone>97239377140</phone>
      <email>kremerm@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emphysema</keyword>
  <keyword>lung transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</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/NCT01682018
org study id: RMC126908
nct id: NCT01682018
lead sponsor: 
has dmc: No
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves
      (Zephyr) would reduce native lung overinflation in patients that underwent single lung
      transplantation due to emphysema, and improve their well being and pulmonary function tests.
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent
      enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of
      pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation
      and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit
      from surgical lung volume reduction and/or lung transplantation. The rationale for lung
      volume reduction surgery is that reducing lung size would restore elastic recoil of the lung
      and improve chest wall and diaphragm mechanics. It has previously been shown that
      particularly patients with heterogeneous emphysema seem to benefit most from surgical lung
      volume reduction.

      Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive
      potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects
      of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively
      occlude the airways supplying the most affected hyperinflated regions of the emphysematous
      lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar
      volume reduction, simulating the effects of surgical LVR.

      The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves
      (Zephyr) would reduce native lung overinflation in patients that underwent single lung
      transplantation due to emphysema, and improve their well being and pulmonary function tests
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: •Mean % change in lung function (FEV1)
time frame: 90 days
measure: Mean change in six minutes walk distance
time frame: 90 days
arm group label: intervention group
arm group type: Experimental
description: Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung
intervention type: Device
intervention name: lung volume reduction using the Zephyr device
description: lung volume reduction using the Zephyr device
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mordechai Kramer Kramer, MD
phone: 97239377140
email: Kremerm@clalit.org.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Pulmonary Emphysema
mesh term: Emphysema