<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/NCT04430140</url>
  </required_header>
  <id_info>
    <org_study_id>19-005543</org_study_id>
    <nct_id>NCT04430140</nct_id>
  </id_info>
  <brief_title>CT Scalar Localization</brief_title>
  <official_title>CT Scalar Localization of the Electrode Array Following Cochlear Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Comparing the location of cochlear implants to level of retained hearing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who have undergone cochlear implant surgery will have a CT scan to determine the&#xD;
      exact anatomical location of the implant. This location will then be compared with audio&#xD;
      testing levels and operative reports to determine any advances in implantation technique that&#xD;
      would result in more preserved hearing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Alternative study opened with ENT services.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Location</measure>
    <time_frame>3 Years</time_frame>
    <description>Determining location of implant using CT scan and correlating retained hearing levels</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cochlear Implant</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>CT Scan&#xD;
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT Scan</intervention_name>
    <description>CT Scan&#xD;
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mayo Clinic Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently scheduled for a cochlear implant or currently have a cochlear implant&#xD;
&#xD;
          -  18 years of age and over&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  Capacity to consent for patients will be determined by review of the medical history&#xD;
             of subject at screening and in concert with the referring physician. Consent will be&#xD;
             signed after all questions have been answered and the participant indicates they&#xD;
             understand&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Current criteria for cochlear implantation&#xD;
&#xD;
          -  Currently pregnant, all females will be asked to take a urine pregnancy test if of&#xD;
             child bearing age, unless you cannot become pregnant&#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>John Lane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>John Lane</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04430140
org study id: 19-005543
nct id: NCT04430140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparing the location of cochlear implants to level of retained hearing.
Subjects who have undergone cochlear implant surgery will have a CT scan to determine the
      exact anatomical location of the implant. This location will then be compared with audio
      testing levels and operative reports to determine any advances in implantation technique that
      would result in more preserved hearing
observational model: Case-Only
time perspective: Prospective
measure: Implant Location
time frame: 3 Years
description: Determining location of implant using CT scan and correlating retained hearing levels
arm group label: 1
description: CT Scan
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6
intervention type: Device
intervention name: CT Scan
description: CT Scan
Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6
arm group label: 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Lane, MD
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: John Lane
investigator title: Principal Investigator
sharing ipd: No