<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/NCT02972970</url>
  </required_header>
  <id_info>
    <org_study_id>Meta-001</org_study_id>
    <nct_id>NCT02972970</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera &quot;Patient Matched&quot; CPAP Mask</brief_title>
  <official_title>Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera &quot;Patient Matched&quot; CPAP Mask</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metamason</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Metamason</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Feasibility study to assess the scan, fit and print process for the Aveera &quot;Patient Matched&quot;&#xD;
      CPAP Mask&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Assess the process of scan, fit and print&#xD;
&#xD;
        2. Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and&#xD;
           comfort&#xD;
&#xD;
        3. Ethnographic insights into the user experience of the scan, fit, print process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">May 16, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit</measure>
    <time_frame>2 weeks</time_frame>
    <description>Assess the clinical utility of using a 3D scanning process, printing and fit assessment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Aveera</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aveera</intervention_name>
    <description>Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use</description>
    <arm_group_label>Aveera</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA&#xD;
&#xD;
          -  Currently CPAP pillows and nasal mask users&#xD;
&#xD;
          -  Patients who are adherent as defined by conventional standards (i.e. 4 hours per&#xD;
             night/70% of the nights)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to wear the AVEERA&#xD;
&#xD;
          -  Concern about privacy of data&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Full face mask user&#xD;
&#xD;
          -  Any medical condition deemed by the investigator to pose an issue with the subject's&#xD;
             participation.&#xD;
&#xD;
          -  Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting&#xD;
             of ≥17cm H2O&#xD;
&#xD;
          -  Requires the use of supplemental oxygen&#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>robyn woidtke</last_name>
    <role>Study Director</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tower Sleep Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>there is no plan to share individual data</ipd_description>
  </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/NCT02972970
org study id: Meta-001
nct id: NCT02972970
lead sponsor: 
has dmc: No
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched"
      CPAP Mask
1. Assess the process of scan, fit and print

        2. Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and
           comfort

        3. Ethnographic insights into the user experience of the scan, fit, print process.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
time frame: 2 weeks
description: Assess the clinical utility of using a 3D scanning process, printing and fit assessment
arm group label: Aveera
arm group type: Other
description: This is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices
intervention type: Device
intervention name: Aveera
description: Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
arm group label: Aveera
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: robyn woidtke
role: Study Director
affiliation: Consultant
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No
ipd description: there is no plan to share individual data