<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/NCT03271970</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00073436</org_study_id>
    <nct_id>NCT03271970</nct_id>
  </id_info>
  <brief_title>The Anatomic Determinants of Perforation Induced Hearing Loss</brief_title>
  <official_title>The Anatomic Determinants of Perforation Induced Hearing Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 purpose of this study is to identify factors that may contribute to conductive hearing&#xD;
      loss. Conductive hearing loss is a type that is due to a problem with the outer or middle&#xD;
      ear. Because of this, sound does not travel through the ear normally. Perforated tympanic&#xD;
      membranes of study patients will be photographed during the patient's routine visit using a&#xD;
      digital otoscope. These pictures will be used to analyze perforation size as an absolute&#xD;
      value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of&#xD;
      temporal bone (reports and images) collected as standard of care will be evaluated. Images of&#xD;
      CT scans will be imported into a medical imaging software for creation of anatomically&#xD;
      realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D&#xD;
      model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be&#xD;
      recorded, and data points will be correlated with perforation size and location to audiogram&#xD;
      results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI no longer wishes to conduct the study. No participants were enrolled.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2017</start_date>
  <completion_date type="Actual">January 3, 2018</completion_date>
  <primary_completion_date type="Actual">January 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>presence of perforation</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of patients with perforations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absence of perforation</measure>
    <time_frame>Day 1</time_frame>
    <description>number of patients without perforations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in audiometric measurements</measure>
    <time_frame>Baseline, up to 16 weeks</time_frame>
    <description>looking at difference between baseline and last observation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Conductive Hearing Loss</condition>
  <condition>Perforated Tympanic Membrane</condition>
  <arm_group>
    <arm_group_label>Patients with conductive hearing loss</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with conductive hearing loss due to tympanic membrane perforation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 89 years of age&#xD;
&#xD;
          -  Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane&#xD;
             perforation&#xD;
&#xD;
          -  Treated for the above condition by a Duke physician&#xD;
&#xD;
          -  Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry&#xD;
             at a Duke-based facility (both tests performed within four weeks of each other), as&#xD;
             part of standard pre-operative workup&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Temporal CT scan with inadequate resolution as per determination of study staff&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Unable to read and understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Frank-Ito, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</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>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
    <mesh_term>Tympanic Membrane Perforation</mesh_term>
  </condition_browse>
  <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/NCT03271970
org study id: Pro00073436
nct id: NCT03271970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify factors that may contribute to conductive hearing
      loss. Conductive hearing loss is a type that is due to a problem with the outer or middle
      ear. Because of this, sound does not travel through the ear normally. Perforated tympanic
      membranes of study patients will be photographed during the patient's routine visit using a
      digital otoscope. These pictures will be used to analyze perforation size as an absolute
      value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of
      temporal bone (reports and images) collected as standard of care will be evaluated. Images of
      CT scans will be imported into a medical imaging software for creation of anatomically
      realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D
      model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be
      recorded, and data points will be correlated with perforation size and location to audiogram
      results.
observational model: Cohort
time perspective: Prospective
measure: presence of perforation
time frame: Day 1
description: Number of patients with perforations
measure: absence of perforation
time frame: Day 1
description: number of patients without perforations
measure: change in audiometric measurements
time frame: Baseline, up to 16 weeks
description: looking at difference between baseline and last observation
arm group label: Patients with conductive hearing loss
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Dennis Frank-Ito, PhD
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Conductive
mesh term: Tympanic Membrane Perforation
sharing ipd: No