<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/NCT03295929</url>
  </required_header>
  <id_info>
    <org_study_id>6815</org_study_id>
    <nct_id>NCT03295929</nct_id>
  </id_info>
  <brief_title>3D Model of Posterior Membranous Labyrinth of the Inner Ear</brief_title>
  <official_title>3D Finite Element Model of Posterior Membranous Labyrinth From in Vivo MRI of Human Temporal Bone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the&#xD;
      human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging&#xD;
      (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in&#xD;
      cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical&#xD;
      studies of vestibular physiology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 19, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of dimensions of the model to study the validity of the geometry</measure>
    <time_frame>Creation of 3D model: 1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Reconstruction of the Posterior Membranous Labyrinth</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult who has performed an imaging of the inner ear&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 or over&#xD;
&#xD;
          -  Adult who has performed an imaging of the inner ear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Anne CHARPIOT, MD, PhD</last_name>
    <phone>33 3 88 12 76 49</phone>
    <email>anne.charpiot@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hella VUONG, MD</last_name>
    <phone>33 6 50 66 82 23</phone>
    <email>hella.vuong@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service D'Orl Et de Chirurgie Cervico-Faciale</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne CHARPIOT, MD, PhD</last_name>
      <phone>33 3 88 12 76 49</phone>
      <email>anne.charpiot@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Hella VUONG, MD</last_name>
      <phone>33 6 50 66 82 23</phone>
      <email>hella.vuong@chru-strasbourg.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Anne CHARPIOT, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hella VUONG, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 23, 2018</last_update_submitted>
  <last_update_submitted_qc>February 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3D model</keyword>
  <keyword>Inner ear</keyword>
  <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/NCT03295929
org study id: 6815
nct id: NCT03295929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the
      human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging
      (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in
      cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical
      studies of vestibular physiology.
observational model: Other
time perspective: Retrospective
measure: Measure of dimensions of the model to study the validity of the geometry
time frame: Creation of 3D model: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Anne CHARPIOT, MD, PhD
phone: 33 3 88 12 76 49
email: anne.charpiot@chru-strasbourg.fr
last name: Hella VUONG, MD
phone: 33 6 50 66 82 23
email: hella.vuong@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No