xml: <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/NCT05992779</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0758</org_study_id>
      <nct_id>NCT05992779</nct_id>
    </id_info>
    <brief_title>Cochlear Implantation in the Elderly</brief_title>
    <acronym>RCIVELDO</acronym>
    <official_title>RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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 goal of this study is to demonstrate that cochlear implantation is an effective,&#xD;
        reasonable, and viable long-term option within a very elderly population&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Actual">May 3, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Vocal audiometry</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Data Loging</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Cochlear</condition>
    <condition>Implant</condition>
    <arm_group>
      <arm_group_label>Patient elderly implanted</arm_group_label>
      <description>Patients over 80 years old, primo implanted between 2011 and 2021</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measuring the vocal audiometry of patients.</intervention_name>
      <description>Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up</description>
      <arm_group_label>Patient elderly implanted</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measuring data loging</intervention_name>
      <description>Measuring data loging at 6 months, 1 year and then annually until last date of follow-up</description>
      <arm_group_label>Patient elderly implanted</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients 80 years or more&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria :&#xD;
  &#xD;
                 -  80 years or more&#xD;
  &#xD;
                 -  Primo-implantation&#xD;
  &#xD;
            -  Exclusion Criteria :&#xD;
  &#xD;
                 -  Under 80 years&#xD;
  &#xD;
                 -  Bilateralisation&#xD;
  &#xD;
                 -  Explantation or re-implantation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>80 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Hôpital Edouard Herriot</name>
        <address>
          <city>Lyon</city>
          <zip>69007</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas BOCQUILLON</last_name>
        <phone>642381137</phone>
        <phone_ext>+33</phone_ext>
        <email>thomas.bocquillon@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>Marjolaine BEAUDOIN</last_name>
        <email>Marjolaine.beaudoin@chu-lyon.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992779
  org study id: 69HCL23_0758
  nct id: NCT05992779
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to demonstrate that cochlear implantation is an effective,
        reasonable, and viable long-term option within a very elderly population
  observational model: Case-Only
  time perspective: Retrospective
  measure: Vocal audiometry
  time frame: Through study completion, an average of 1 year
  measure: Data Loging
  time frame: Through study completion, an average of 1 year
  arm group label: Patient elderly implanted
  description: Patients over 80 years old, primo implanted between 2011 and 2021
  intervention type: Other
  intervention name: Measuring the vocal audiometry of patients.
  description: Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up
  arm group label: Patient elderly implanted
  intervention type: Other
  intervention name: Measuring data loging
  description: Measuring data loging at 6 months, 1 year and then annually until last date of follow-up
  arm group label: Patient elderly implanted
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 80 Years
  maximum age: N/A
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor