<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/NCT03034421</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol G1.1 - 17.04.2016</org_study_id>
    <nct_id>NCT03034421</nct_id>
  </id_info>
  <brief_title>Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema</brief_title>
  <official_title>Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg University</source>
  <brief_summary>
    <textblock>
      Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low&#xD;
      interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment&#xD;
      approach, it is associated with complications the most common of which is pneumothorax with a&#xD;
      rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after&#xD;
      valve implantation may reduce the risk of post-interventional pneumothorax.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient enrolment and data acquisition is to be carried out on a prospective basis. It is&#xD;
      planned to enrol a total of 130 patients with advanced emphysema and low collateral&#xD;
      ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical&#xD;
      care including a 48 bed rest or standard medical care following valve implantation. All&#xD;
      patients will undergo treatment at one study centre in Heidelberg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficult patient recruitment&#xD;
  </why_stopped>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Advent of pneumothorax within 90 days following valve implantation</measure>
    <time_frame>90 days following valve implantation</time_frame>
    <description>Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung function before and after valve therapy</measure>
    <time_frame>30 and 90 days following valve implantation</time_frame>
    <description>Lung function parameters (VC [L], FEV1 [L], RV [L], TLC [L] will be assessed 30 and 90 days following valve implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excercise capacity before and after valve therapy</measure>
    <time_frame>30 and 90 days following valve implantation</time_frame>
    <description>6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnoe score before and after valve therapy</measure>
    <time_frame>30 and 90 days following valve implantation</time_frame>
    <description>Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Pneumothorax</condition>
  <arm_group>
    <arm_group_label>Modified medical care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo 48-hours bed rest after endoscopic valve implantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard medical care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bed rest</intervention_name>
    <description>Patients will undergo bed rest for 48 hours following endoscopic valve implantation.</description>
    <arm_group_label>Modified medical care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FEV1 &lt; 50%, RV&gt;150%, TLC&gt;100%&#xD;
&#xD;
          -  emphysema confirmed by computed tomography&#xD;
&#xD;
          -  pO2 &gt;60 mmHg (with supplemental oxygen), pCO2 &lt; 55 mmHg (room condition)&#xD;
&#xD;
          -  no significant collateral ventilation (assessed by fissure analysis and/or&#xD;
             catheter-based measurement)&#xD;
&#xD;
          -  no COPD exacerbation within the past 8 weeks&#xD;
&#xD;
          -  daily use of &lt; 20 mg Prednisolon&#xD;
&#xD;
          -  non-smoking for a minimum of 4 months prior to consent&#xD;
&#xD;
          -  Patient has provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt; 18 kg/m²&#xD;
&#xD;
          -  clinically relevant bronchiectasis&#xD;
&#xD;
          -  failed cardiac clearance: defined as myocardial infarction within last 6 weeks,&#xD;
             decompensation of heart failure&#xD;
&#xD;
          -  Prior lung resection (e.g. lobectomy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniela Gompelmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thoraxklinik at University of Heidelberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>July 4, 2022</last_update_submitted>
  <last_update_submitted_qc>July 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Felix JF Herth</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</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/NCT03034421
org study id: Protocol G1.1 - 17.04.2016
nct id: NCT03034421
lead sponsor: 
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low
      interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment
      approach, it is associated with complications the most common of which is pneumothorax with a
      rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after
      valve implantation may reduce the risk of post-interventional pneumothorax.
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is
      planned to enrol a total of 130 patients with advanced emphysema and low collateral
      ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical
      care including a 48 bed rest or standard medical care following valve implantation. All
      patients will undergo treatment at one study centre in Heidelberg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Advent of pneumothorax within 90 days following valve implantation
time frame: 90 days following valve implantation
description: Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
measure: Lung function before and after valve therapy
time frame: 30 and 90 days following valve implantation
description: Lung function parameters (VC [L], FEV1 [L], RV [L], TLC [L] will be assessed 30 and 90 days following valve implantation.
measure: Excercise capacity before and after valve therapy
time frame: 30 and 90 days following valve implantation
description: 6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.
measure: Dyspnoe score before and after valve therapy
time frame: 30 and 90 days following valve implantation
description: Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.
arm group label: Modified medical care
arm group type: Active Comparator
description: Patients will undergo 48-hours bed rest after endoscopic valve implantation.
arm group label: Standard medical care
arm group type: No Intervention
description: Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.
intervention type: Behavioral
intervention name: Bed rest
description: Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
arm group label: Modified medical care
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Daniela Gompelmann, MD
role: Principal Investigator
affiliation: Thoraxklinik at University of Heidelberg
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Felix JF Herth
investigator title: Prof. Dr. med.
mesh term: Pneumothorax
mesh term: Emphysema