<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/NCT02996149</url>
  </required_header>
  <id_info>
    <org_study_id>PV-5379</org_study_id>
    <nct_id>NCT02996149</nct_id>
  </id_info>
  <brief_title>Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure</brief_title>
  <official_title>Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <brief_summary>
    <textblock>
      Endoscopic lung volume reduction coil treatment is a treatment option for selected patients&#xD;
      with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic&#xD;
      respiratory failure. In this observational study the safety and efficacy of endoscopic lung&#xD;
      volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Technique no longer available&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in PaCO2</measure>
    <time_frame>3 months after endoscopic lung volume reduction (ELVR)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in PaCO2</measure>
    <time_frame>6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FEV1</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vital capacity</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in residual volume</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 6-minute walk distance</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in BMI</measure>
    <time_frame>3, 6 and 12 months after ELVR</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Emphysema</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic lung volume reduction coil treatment</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom&#xD;
        endoscopic lung volume reduction coil treatment is performed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with emphysema (chronic obstructive pulmonary disease with forced expired&#xD;
             volume in one second (FEV1) &lt; 50% predicted and residual volume (RV) ≥ 200% predicted)&#xD;
             in whom endoscopic lung volume reduction coil treatment is performed&#xD;
&#xD;
          -  Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Therapeutic anticoagulation&#xD;
&#xD;
          -  Anti-platelet therapy exceeding the use of acetylsalicylic acid&#xD;
&#xD;
          -  Severe pulmonary hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
    <investigator_full_name>Dr. Hans Klose</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT02996149
org study id: PV-5379
nct id: NCT02996149
lead sponsor: 
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients
      with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic
      respiratory failure. In this observational study the safety and efficacy of endoscopic lung
      volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is
      evaluated.
observational model: Case-Only
time perspective: Prospective
measure: Changes in PaCO2
time frame: 3 months after endoscopic lung volume reduction (ELVR)
measure: Changes in PaCO2
time frame: 6 and 12 months after ELVR
measure: Changes in FEV1
time frame: 3, 6 and 12 months after ELVR
measure: Changes in vital capacity
time frame: 3, 6 and 12 months after ELVR
measure: Changes in residual volume
time frame: 3, 6 and 12 months after ELVR
measure: Changes in 6-minute walk distance
time frame: 3, 6 and 12 months after ELVR
measure: Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)
time frame: 3, 6 and 12 months after ELVR
measure: Changes in BMI
time frame: 3, 6 and 12 months after ELVR
intervention type: Procedure
intervention name: Endoscopic lung volume reduction coil treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
investigator full name: Dr. Hans Klose
investigator title: Dr.
mesh term: Respiratory Insufficiency
mesh term: Emphysema