<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/NCT03008226</url>
  </required_header>
  <id_info>
    <org_study_id>TKSPI 001/2014</org_study_id>
    <nct_id>NCT03008226</nct_id>
  </id_info>
  <brief_title>Spiration Valve System 9 mm European Post Market Evaluation Study</brief_title>
  <official_title>Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lung Clinic Hemer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asklepios Kliniken Hamburg GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Otto Wagner Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial&#xD;
      valve treatment in patients with heterogeneous emphysema and to gain further insights and&#xD;
      experience on the treatment with this valve size.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate performance of the 9 mm valve system in patients with at&#xD;
      least one airway to be treated . Patients with severe airflow obstruction, severe emphysema,&#xD;
      significant hyperinflation, and moderate to severe dyspnea are eligible to be evaluated for&#xD;
      enrollment in this study. In this study, eligible patients will have severe emphysema in a&#xD;
      target lobe with an intact fissure. Patients must be able to tolerate a flexible bronchoscopy&#xD;
      procedure. After evaluation of all inclusion and exclusion criteria, with review of the CT&#xD;
      data by the core laboratories, patients will be enrolled in the study. The indications for&#xD;
      endoscopic reduction of pulmonary volume with intrabronchial valves are presented in various&#xD;
      preliminary examinations. The duration of the study is about 7 months for each patient. It&#xD;
      involves an examination before the valves are inserted, the valves are inserted within the&#xD;
      scope of a bronchoscopy, followed by a follow-up examination directly after the valves are&#xD;
      inserted, a follow-up period of at least 3 nights in the appropriate clinic and follow-up&#xD;
      visits 14, 30 each , 90 and 180 days after the valves are inserted.&#xD;
&#xD;
      The study is expected to enroll up to 30 patients who complete the 6 month follow-up visit at&#xD;
      up to 4 sites with up to 15 patients per site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Mean changes in target lobe volume</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Emphysema</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implementation of 9 mm intrabronchial valves</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and&#xD;
        moderate to severe dyspnea . Eligible patients will have severe emphysema in a target lobe&#xD;
        with an intact fissure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is older than 40 years in age&#xD;
&#xD;
          -  Patient has severe heterogeneous emphysema with moderate to severe dyspnea as defined&#xD;
             as an mMRC of 2 or greater.&#xD;
&#xD;
          -  The target lobe and ipsilateral lobe will be separated with an intact fissure, as&#xD;
             determined by HRCT (&gt; 90% integrity).&#xD;
&#xD;
          -  Patient has received standard-of-care medical management and it has been stable for 6&#xD;
             weeks.&#xD;
&#xD;
          -  Patient can walk a minimum of 140 meters in the six minute walk test.&#xD;
&#xD;
          -  Patient's obstructive disease is severe as defined by: FEV1 ≤45% of predicted&#xD;
&#xD;
          -  Patient's hyperinflation is defined by: RV ≥ 150% of predicted&#xD;
&#xD;
          -  Patient is willing to participate in a study, complete the required follow-up visits,&#xD;
             and maintain consistent nutrition and exercise habits during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient does not have at least one airway with the intention to be treated with a 9 mm&#xD;
             Spiration Valve based on a calibrated balloon sizing of the airway.&#xD;
&#xD;
          -  Patient has co-existing major medical disease that will limit evaluation,&#xD;
             participation, or follow-up in the study&#xD;
&#xD;
          -  Patient is unable to provide informed consent&#xD;
&#xD;
          -  Patient is not an appropriate candidate for or is unable to tolerate, flexible&#xD;
             bronchoscopy procedures&#xD;
&#xD;
          -  Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory&#xD;
             infections in the past year and none have occurred in the 3 months prior to baseline&#xD;
             testing.&#xD;
&#xD;
          -  Patient has giant bulla (&gt; 1/3 volume of lung)&#xD;
&#xD;
          -  Patient has severe pulmonary hypertension.&#xD;
&#xD;
          -  Patient has bronchiectasis&#xD;
&#xD;
          -  Patient has evidence of systemic disease or neoplasia expected to compromise survival&#xD;
             during the 6-month study period&#xD;
&#xD;
          -  Patient has had prior lung volume reduction surgery, intra-bronchial valve therapy for&#xD;
             emphysema, or major lung procedures (lobectomy or greater).&#xD;
&#xD;
          -  Patient has demonstrated unwillingness or inability to complete screening or baseline&#xD;
             data collection procedures.&#xD;
&#xD;
          -  Patient participated in a study of an investigational drug or device within the past&#xD;
             30 days prior to participation in this study, or is currently participating in another&#xD;
             clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felix Herth, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Heidelberg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Felix Herth, Prof.</last_name>
    <phone>+49(0)6221/3961201</phone>
    <email>herth@uni-heidelberg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thoraxklinik, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Herth, Prof-</last_name>
      <phone>+49(0)6221/3961201</phone>
      <email>herth@uni-heidelberg.de</email>
    </contact>
    <investigator>
      <last_name>Felix JF Herth, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</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>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03008226
org study id: TKSPI 001/2014
nct id: NCT03008226
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial
      valve treatment in patients with heterogeneous emphysema and to gain further insights and
      experience on the treatment with this valve size.
This study is designed to evaluate performance of the 9 mm valve system in patients with at
      least one airway to be treated . Patients with severe airflow obstruction, severe emphysema,
      significant hyperinflation, and moderate to severe dyspnea are eligible to be evaluated for
      enrollment in this study. In this study, eligible patients will have severe emphysema in a
      target lobe with an intact fissure. Patients must be able to tolerate a flexible bronchoscopy
      procedure. After evaluation of all inclusion and exclusion criteria, with review of the CT
      data by the core laboratories, patients will be enrolled in the study. The indications for
      endoscopic reduction of pulmonary volume with intrabronchial valves are presented in various
      preliminary examinations. The duration of the study is about 7 months for each patient. It
      involves an examination before the valves are inserted, the valves are inserted within the
      scope of a bronchoscopy, followed by a follow-up examination directly after the valves are
      inserted, a follow-up period of at least 3 nights in the appropriate clinic and follow-up
      visits 14, 30 each , 90 and 180 days after the valves are inserted.

      The study is expected to enroll up to 30 patients who complete the 6 month follow-up visit at
      up to 4 sites with up to 15 patients per site.
observational model: Case-Only
time perspective: Prospective
measure: Mean changes in target lobe volume
time frame: 180 days
intervention type: Device
intervention name: Implementation of 9 mm intrabronchial valves
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Felix Herth, Prof.Dr.med.
role: Principal Investigator
affiliation: University Heidelberg
last name: Felix Herth, Prof.
phone: +49(0)6221/3961201
email: herth@uni-heidelberg.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Felix JF Herth
investigator title: Prof. Dr. med.
mesh term: Pulmonary Emphysema
mesh term: Emphysema
sharing ipd: No