<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/NCT01719263</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-1570</org_study_id>
    <nct_id>NCT01719263</nct_id>
  </id_info>
  <brief_title>Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study</brief_title>
  <official_title>Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uptake Medical Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uptake Medical Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to demonstrate safety and efficacy in patients with severe upper lobe&#xD;
      predominant emphysema. For validity of the study, the results will be compared to patients&#xD;
      that receive optimal medical therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced expiratory volume in 1-second (FEV1) compared to active comparator</measure>
    <time_frame>Year 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (SGRQ)</measure>
    <time_frame>Year 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder rate for FEV1 % difference from baseline</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate SGRQ pts difference from baseline</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate 6MWD meter difference from baseline</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lobar Volume Reduction HRCT</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>Treatment plus Optimal Medical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with the InterVapor System and Optimal Medical Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optimal Medical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated according to Optimal Medical Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InterVapor® treatment plus Optimal Medical Therapy</intervention_name>
    <description>Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).</description>
    <arm_group_label>Treatment plus Optimal Medical Therapy</arm_group_label>
    <other_name>InterVapor or BTVA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optimal Medical Therapy</intervention_name>
    <description>Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).</description>
    <arm_group_label>Optimal Medical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heterogeneous emphysema with upper lobe predominance in both lungs&#xD;
&#xD;
          -  FEV1 between 20% and 45% predicted&#xD;
&#xD;
          -  Residual volume (RV) &gt; 150% predicted&#xD;
&#xD;
          -  Post-rehabilitation 6-minute walk test &gt; 140 meters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 3 COPD related hospitalizations requiring antibiotics in past 12 months&#xD;
&#xD;
          -  FEV1 &lt; 20% predicted&#xD;
&#xD;
          -  DLCO &lt; 20% predicted or immeasurable DLCO&#xD;
&#xD;
          -  Body mass index (BMI) &lt; 18kg/m2 or &gt; 32 kg/m2&#xD;
&#xD;
          -  History of any of the following:&#xD;
&#xD;
               -  Left ventricular ejection fraction (EF) ≤ 40%&#xD;
&#xD;
               -  Stroke&#xD;
&#xD;
               -  Myocardial infarction or acute coronary syndrome in previous year&#xD;
&#xD;
               -  Hospitalization due to left ventricular failure in previous 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felix JF Herth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heidelberg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Snell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Alfred Hospital, Melbourne, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otto-Wagner-Spital</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitätsmedizin Berlin Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftskrankenhaus Havelhöhe Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>14089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Fachkliniken Gauting München</name>
      <address>
        <city>Gauting</city>
        <zip>82131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Schillerhohe</name>
      <address>
        <city>Gerlingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Halle</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Harburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungenklinik Hemer</name>
      <address>
        <city>Hemer</city>
        <zip>58675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg</name>
      <address>
        <city>Nuernberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1051</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bromptom &amp; Harefield NHS Foundation</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 27, 2015</last_update_submitted>
  <last_update_submitted_qc>October 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emphysema</keyword>
  <keyword>InterVapor</keyword>
  <keyword>treatments</keyword>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>lung volume reduction</keyword>
  <keyword>endoscopic lung volume reduction</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/NCT01719263
org study id: CSP-1570
nct id: NCT01719263
lead sponsor: 
has dmc: No
This study is designed to demonstrate safety and efficacy in patients with severe upper lobe
      predominant emphysema. For validity of the study, the results will be compared to patients
      that receive optimal medical therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Forced expiratory volume in 1-second (FEV1) compared to active comparator
time frame: Year 1
measure: Quality of Life (SGRQ)
time frame: Year 1
measure: Responder rate for FEV1 % difference from baseline
time frame: Year 1
measure: Responder rate SGRQ pts difference from baseline
time frame: Year 1
measure: Responder rate 6MWD meter difference from baseline
time frame: Year 1
measure: Lobar Volume Reduction HRCT
time frame: Year 1
arm group label: Treatment plus Optimal Medical Therapy
arm group type: Experimental
description: Patients will be treated with the InterVapor System and Optimal Medical Therapy
arm group label: Optimal Medical Therapy
arm group type: Active Comparator
description: Patients will be treated according to Optimal Medical Therapy
intervention type: Device
intervention name: InterVapor® treatment plus Optimal Medical Therapy
description: Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
arm group label: Treatment plus Optimal Medical Therapy
other name: InterVapor or BTVA
intervention type: Other
intervention name: Optimal Medical Therapy
description: Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
arm group label: Optimal Medical Therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Felix JF Herth, MD
role: Principal Investigator
affiliation: Heidelberg University
last name: Gregory Snell, MD
role: Principal Investigator
affiliation: The Alfred Hospital, Melbourne, Australia
facility: 
facility: 
facility: 
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facility: 
facility: 
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facility: 
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country: Australia
country: Austria
country: Germany
country: Ireland
country: New Zealand
country: United Kingdom
responsible party type: Sponsor
mesh term: Pulmonary Emphysema
mesh term: Emphysema