<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/NCT01720680</url>
  </required_header>
  <id_info>
    <org_study_id>PML_DOC_1202</org_study_id>
    <nct_id>NCT01720680</nct_id>
  </id_info>
  <brief_title>Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD</brief_title>
  <official_title>Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore®&#xD;
           device on central and peripheral airway dimensions in patients with COPD.&#xD;
&#xD;
        -  Indication: COPD patients&#xD;
&#xD;
        -  Study Design: Open-label, prospective design&#xD;
&#xD;
        -  Study Phase: II&#xD;
&#xD;
        -  Test treatment duration: 1 day&#xD;
&#xD;
        -  Test treatment: AlphaCore® device&#xD;
&#xD;
        -  Dosage regimen: 1 session of stimulation during 90 seconds&#xD;
&#xD;
        -  Patient number: up to 10 evaluable patients with COPD&#xD;
&#xD;
        -  Patient age: ≥ 18 years&#xD;
&#xD;
        -  Sex: male or female&#xD;
&#xD;
        -  Primary objective: The evaluation of the effect of the AlphaCore® device on central and&#xD;
           peripheral airway dimensions with Computational Fluid Dynamics (CFD).&#xD;
&#xD;
        -  Secondary objectives: The assessment of the effect of the AlphaCore® device on lung&#xD;
           function (spirometry, diffusion and resistance) and on patient reported outcomes&#xD;
           (PRO's).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>N/A</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>Changes in functional imaging parameters</measure>
    <time_frame>At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device</time_frame>
    <description>The primary objective of this study is to evaluate the effect of the AlphaCore® on central and peripheral airway dimensions with functional imaging using airway segmentation and computational methods (CFD).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in lung function parameters</measure>
    <time_frame>At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device</time_frame>
    <description>The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reports outcomes (PROs)</measure>
    <time_frame>At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)</time_frame>
    <description>The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.</description>
  </secondary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>COPD</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low dose multislice CT thorax</intervention_name>
    <description>All patients will have 2 low dose multi-slice CT's at visit 2: one CT &quot;pre-dose&quot; and one CT 1 to 3 hours &quot;post-dose&quot;.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AlphaCore® device</intervention_name>
    <description>All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a documented diagnosis of COPD&#xD;
&#xD;
          -  Male or female patients aged ≥18 years&#xD;
&#xD;
          -  Patients with a co-operative attitude to be treated with the AlphaCore® device&#xD;
&#xD;
          -  Patients should take anti-cholinergics&#xD;
&#xD;
          -  Female patient of childbearing potential who confirm to use a contraception method&#xD;
             during the study&#xD;
&#xD;
          -  Written informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females or females at risk of pregnancy at screening and not&#xD;
             willing to use an appropriate contraception method during the study period&#xD;
&#xD;
          -  Inability to carry out pulmonary function testing&#xD;
&#xD;
          -  Patients with an uncontrolled disease or any condition that might, in the judgement of&#xD;
             the investigator, place the patient at undue risk or potentially compromise the&#xD;
             results or interpretation of the study&#xD;
&#xD;
          -  Patients with an electrical and/or neurostimulator device (e.g. a cardiac pacemaker, a&#xD;
             vagal neurostimulator, a defibrillator, a cochlear implant, …)&#xD;
&#xD;
          -  Patients with an abscess or other infection or lesion (incl. lymphadenopathy) at the&#xD;
             therapy head placement site&#xD;
&#xD;
          -  Patients with a compromised cervical anatomy (such as from scaring, infection or&#xD;
             suspected carotid artery disease) or a cervical vagotomy&#xD;
&#xD;
          -  Patients with a history of carotid endarterectomy or vascular neck surgery on the&#xD;
             right side&#xD;
&#xD;
          -  Patients with coagulopathy, irregular heart rhythm or that are on pressor medication&#xD;
&#xD;
          -  Patients unlikely to comply with the protocol or unable to understand the nature,&#xD;
             scope and possible consequences of the study&#xD;
&#xD;
          -  Patients who received any investigational new drug within the last 4 weeks prior to&#xD;
             the screening visit&#xD;
&#xD;
          -  Patients treated with any non-permitted concomitant medication&#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>Wilfried De Backer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>June 27, 2013</last_update_submitted>
  <last_update_submitted_qc>June 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 28, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Wilfried De Backer</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Functional Imaging</keyword>
  <keyword>Patient Reported Outcome (PRO)</keyword>
  <keyword>Lung Function</keyword>
  <keyword>AlphaCore</keyword>
  <keyword>Computational Fluid Dynamics</keyword>
  <!-- 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/NCT01720680
org study id: PML_DOC_1202
nct id: NCT01720680
lead sponsor: 
has dmc: No
-  Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore®
           device on central and peripheral airway dimensions in patients with COPD.

        -  Indication: COPD patients

        -  Study Design: Open-label, prospective design

        -  Study Phase: II

        -  Test treatment duration: 1 day

        -  Test treatment: AlphaCore® device

        -  Dosage regimen: 1 session of stimulation during 90 seconds

        -  Patient number: up to 10 evaluable patients with COPD

        -  Patient age: ≥ 18 years

        -  Sex: male or female

        -  Primary objective: The evaluation of the effect of the AlphaCore® device on central and
           peripheral airway dimensions with Computational Fluid Dynamics (CFD).

        -  Secondary objectives: The assessment of the effect of the AlphaCore® device on lung
           function (spirometry, diffusion and resistance) and on patient reported outcomes
           (PRO's).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in functional imaging parameters
time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
description: The primary objective of this study is to evaluate the effect of the AlphaCore® on central and peripheral airway dimensions with functional imaging using airway segmentation and computational methods (CFD).
measure: Changes in lung function parameters
time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
description: The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.
measure: Changes in patient reports outcomes (PROs)
time frame: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)
description: The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.
intervention type: Radiation
intervention name: Low dose multislice CT thorax
description: All patients will have 2 low dose multi-slice CT's at visit 2: one CT "pre-dose" and one CT 1 to 3 hours "post-dose".
intervention type: Device
intervention name: AlphaCore® device
description: All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wilfried De Backer, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Antwerp
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Wilfried De Backer
investigator title: Prof. Dr.