<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/NCT02246569</url>
  </required_header>
  <id_info>
    <org_study_id>14-001</org_study_id>
    <nct_id>NCT02246569</nct_id>
  </id_info>
  <brief_title>Lung Volume Reduction Via Coils in Patients With COPD</brief_title>
  <official_title>Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for&#xD;
      the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the&#xD;
      insertion of the coils distended lung sections shrink so that healthy parts can expand.&#xD;
&#xD;
      In the present study investigators intend to examine, whether the insertion of the coils&#xD;
      improves diaphragm function and force of the breathing muscles. Investigators hypothesize&#xD;
      that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves&#xD;
      breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In line with routine explorations it is necessary to clarify whether a patient is suitable&#xD;
      for the endoscopic lung volume reduction. To address this question lung function diagnostics,&#xD;
      6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and&#xD;
      transthoracic echocardiography have to be performed.&#xD;
&#xD;
      After confirmation of the suitability for the endoscopic lung volume reduction patients who&#xD;
      fulfill all other eligibility criteria will be educated about the aim and performance of the&#xD;
      study by an investigator. After reading the patient information patient may submit his&#xD;
      informed written consent. After that information on the risks will be given by a treating&#xD;
      physician.&#xD;
&#xD;
      Following examination will be performed additional due to the study: determination of the&#xD;
      strength of breathing muscles, determination of the life quality index via&#xD;
      St.-George-questionary and determination of the depression score via SF-8-questionary (short&#xD;
      form-8).&#xD;
&#xD;
      After that coils will be implanted and a permanent post-operative examination will be&#xD;
      performed for 24 hours.&#xD;
&#xD;
      Three, respectively nine month after the implanting follow up exploration will be performed&#xD;
      on the study patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>breathing strength</measure>
    <time_frame>Change of breathing strength 3 (respectively 9) months after the bronchoscopy</time_frame>
    <description>Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with severe COPD (GOLD stage III or IV)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu&#xD;
             Coil implantation at the discretion of the treating physicians&#xD;
&#xD;
          -  homogeneous or heterogeneous emphysema&#xD;
&#xD;
          -  previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal&#xD;
             infections and seasonal influenza)&#xD;
&#xD;
          -  nicotine abstention for not less than three months, documented by CO-HB (haemoglobin)&#xD;
             &lt; 2%&#xD;
&#xD;
          -  FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value,&#xD;
             after bronchodilatation&#xD;
&#xD;
          -  total lung capacity (TLC) ≥ 100% of reference value&#xD;
&#xD;
          -  residual volume (RV) ≥ 175% of reference value&#xD;
&#xD;
          -  patient's suitability for endoscopic lung volume reduction according to&#xD;
             multidisciplinary decision of pneumology and thorax surgery division.&#xD;
&#xD;
          -  signed Informed Consent&#xD;
&#xD;
          -  understanding of the nature, significance and implications of the study&#xD;
&#xD;
          -  ability to understand and follow instructions of the study stuff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  echo-cardiographic right ventricular pressure (PAPsys) &gt; 50 mmHg&#xD;
&#xD;
          -  indication for a permanent anticoagulation therapy (besides ASS)&#xD;
&#xD;
          -  pulmonal cachexia&#xD;
&#xD;
          -  pregnancy and lactating&#xD;
&#xD;
          -  permanent treatment with &gt; 20 mg Prednison per day&#xD;
&#xD;
          -  hospitalisation due to a COPD-exacerbation in the last 3 months&#xD;
&#xD;
          -  &gt; 3 steroid-treated exacerbations in the last year&#xD;
&#xD;
          -  Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation&#xD;
&#xD;
          -  severe diffusion impairment (DLCO &lt; 20%)&#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>Michael Dreher, Univ.-Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>RWTH University Hospital MK1</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Dreher, Univ.-Prof.</last_name>
    <phone>+49241 80 88763</phone>
    <email>mdreher@ukaachen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tobias Müller, PD Dr.med.</last_name>
    <phone>+49241 80 88763</phone>
    <email>tobmueller@ukaachen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>RWTH Univerity Hospital MK1</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Dreher, Univ.-Prof.</last_name>
      <phone>+492418088763</phone>
      <email>mdreher@ukaachen.de</email>
    </contact>
    <contact_backup>
      <last_name>Tobias Müller, PD Dr.med.</last_name>
      <phone>+492418088763</phone>
      <email>tobmueller@ukaachen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic obstructive pulmonary disease (COPD)</keyword>
  <keyword>endoscopic lung volume reduction</keyword>
  <keyword>RePneu®Coils</keyword>
  <keyword>physical capacity</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02246569
org study id: 14-001
nct id: NCT02246569
lead sponsor: 
has dmc: No
For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for
      the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the
      insertion of the coils distended lung sections shrink so that healthy parts can expand.

      In the present study investigators intend to examine, whether the insertion of the coils
      improves diaphragm function and force of the breathing muscles. Investigators hypothesize
      that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves
      breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.
In line with routine explorations it is necessary to clarify whether a patient is suitable
      for the endoscopic lung volume reduction. To address this question lung function diagnostics,
      6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and
      transthoracic echocardiography have to be performed.

      After confirmation of the suitability for the endoscopic lung volume reduction patients who
      fulfill all other eligibility criteria will be educated about the aim and performance of the
      study by an investigator. After reading the patient information patient may submit his
      informed written consent. After that information on the risks will be given by a treating
      physician.

      Following examination will be performed additional due to the study: determination of the
      strength of breathing muscles, determination of the life quality index via
      St.-George-questionary and determination of the depression score via SF-8-questionary (short
      form-8).

      After that coils will be implanted and a permanent post-operative examination will be
      performed for 24 hours.

      Three, respectively nine month after the implanting follow up exploration will be performed
      on the study patients.
time perspective: Prospective
measure: breathing strength
time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
description: Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Dreher, Univ.-Prof.
role: Principal Investigator
affiliation: RWTH University Hospital MK1
last name: Michael Dreher, Univ.-Prof.
phone: +49241 80 88763
email: mdreher@ukaachen.de
last name: Tobias Müller, PD Dr.med.
phone: +49241 80 88763
email: tobmueller@ukaachen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive