<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/NCT01716598</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-002</org_study_id>
    <secondary_id>CVI-12-03-005102</secondary_id>
    <nct_id>NCT01716598</nct_id>
  </id_info>
  <brief_title>Evaluation of the IPS System for TLD Therapy in Patients With COPD</brief_title>
  <acronym>IPS-II</acronym>
  <official_title>IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nuvaira, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nuvaira, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve&#xD;
      trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve&#xD;
      targeted lung denervation and potentially improve breathing and quality of life for patients&#xD;
      suffering from COPD.&#xD;
&#xD;
      Use of the IPS System will be technically feasible in accessing the target treatment location&#xD;
      and delivering RF energy to the target treatment location.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Safety Endpoint</measure>
    <time_frame>365 Days</time_frame>
    <description>Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>365 days</time_frame>
    <description>Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Targeted Lung Denervation Therapy (TLD Therapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IPS System</intervention_name>
    <description>TLD Therapy will be achieved bronchoscopically.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>TLD Therapy</other_name>
    <other_name>Targeted Lung Denervation Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FEV1 30% to 60%&#xD;
&#xD;
          -  Patient is diagnosed with COPD&#xD;
&#xD;
          -  Positive relative change in FEV1 of greater than 15%&#xD;
&#xD;
          -  Patient 40 years of age or older at the time of consent&#xD;
&#xD;
          -  Smoking history of at least 10 pack years&#xD;
&#xD;
          -  Non-smoking for a minimum of 6 months prior to consent and agrees to continue not&#xD;
             smoking for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented history or current evidence of pulmonary hypertension Documented history or&#xD;
             current evidence of polycythemia level of greater&#xD;
&#xD;
          -  Documented history or current evidence of congestive heart failure&#xD;
&#xD;
          -  Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa&#xD;
             (55 mm Hg) on room air&#xD;
&#xD;
          -  Patient has a PaCO2 &gt; 8.0 kPa (60 mm Hg)&#xD;
&#xD;
          -  Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy&#xD;
&#xD;
          -  Pulmonary nodule requiring surgery&#xD;
&#xD;
          -  History of recurrent respiratory infections (more than 3 hospitalizations within 1&#xD;
             year of enrollment)&#xD;
&#xD;
          -  Presence of a pacemaker, internal defibrillator or other implantable electronic&#xD;
             devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation&#xD;
             within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m.&#xD;
             Unstable or life threatening arrhythmia within the last year n. Malignancy treated&#xD;
             with radiation or chemotherapy within the last 2 years o. Documented history of other&#xD;
             respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction,&#xD;
             Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arschang Valipour, MD, FCCP, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Otto-Wagner Hospital, Vienna, Austria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Otto-Wagner Hospital and Medical Center</name>
      <address>
        <city>Sanatoriumstrasse 2</city>
        <state>Vienna</state>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier et Universitaire de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier University de Reims</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvel Hopital Civil</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>September 22, 2016</last_update_submitted>
  <last_update_submitted_qc>September 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>TLD Therapy</keyword>
  <keyword>Targeted Lung Denervation Therapy</keyword>
  <keyword>IPS</keyword>
  <keyword>Innovative Pulmonary Solutions, Inc.</keyword>
  <keyword>Holaira, Inc.</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/NCT01716598
org study id: CLP-002
secondary id: CVI-12-03-005102
nct id: NCT01716598
lead sponsor: 
has dmc: Yes
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve
      trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve
      targeted lung denervation and potentially improve breathing and quality of life for patients
      suffering from COPD.

      Use of the IPS System will be technically feasible in accessing the target treatment location
      and delivering RF energy to the target treatment location.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Safety Endpoint
time frame: 365 Days
description: Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
measure: Performance
time frame: 365 days
description: Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation.
arm group label: Treatment
arm group type: Experimental
description: Targeted Lung Denervation Therapy (TLD Therapy)
intervention type: Device
intervention name: IPS System
description: TLD Therapy will be achieved bronchoscopically.
arm group label: Treatment
other name: TLD Therapy
other name: Targeted Lung Denervation Therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Arschang Valipour, MD, FCCP, Ass. Prof.
role: Principal Investigator
affiliation: Otto-Wagner Hospital, Vienna, Austria
facility: 
facility: 
facility: 
facility: 
country: Austria
country: France
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive