<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/NCT02969993</url>
  </required_header>
  <id_info>
    <org_study_id>2016/394</org_study_id>
    <nct_id>NCT02969993</nct_id>
  </id_info>
  <brief_title>Very Long Term VHI Voice Outcome After MTIS</brief_title>
  <official_title>Very Long Term VHI Voice Outcome After MTIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of&#xD;
      operated patients using the voice handicap index scale&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 19, 2017</completion_date>
  <primary_completion_date type="Actual">October 17, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Voice handicap index</measure>
    <time_frame>2 years</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Laryngeal Paralysis</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaire to previously operated patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>evaluating the voice outcome by the fullfilment of the voice handicap index</description>
    <arm_group_label>Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients presenting UVFP of neurogenic origin treated by MTIS &gt; 2 years before&#xD;
             inclusion.&#xD;
&#xD;
          -  No superior limit in terms of years.&#xD;
&#xD;
          -  Age 18-80 years at the time of MTIS&#xD;
&#xD;
          -  No other treatment before MTIS other than resorbing material injection laryngoplasty&#xD;
             (maximum twice)&#xD;
&#xD;
          -  No further voice treatment after MTIS except speech therapy.&#xD;
&#xD;
          -  VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of&#xD;
             multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into&#xD;
             account&#xD;
&#xD;
          -  VHI tests validated for the utilized language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient not able to answer VHI questionnaire personally&#xD;
&#xD;
          -  Post MTIS new health condition affecting the voice tract and/ or the respiratory&#xD;
             function.&#xD;
&#xD;
          -  Post MTIS appearance of other voice/ vocal cord pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels Capital Region</city>
        <state>Brussels</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Namur -Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <state>Namur</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valencia Medical School - Hospital General Universitario</name>
      <address>
        <city>Valencia</city>
        <state>Levante</state>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Spain</country>
  </location_countries>
  <removed_countries>
    <country>Mexico</country>
  </removed_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 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>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02969993
org study id: 2016/394
nct id: NCT02969993
lead sponsor: 
has dmc: No
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of
      operated patients using the voice handicap index scale
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Voice handicap index
time frame: 2 years
description: Questionnaire
arm group label: Questionnaire
arm group type: Experimental
description: Questionnaire to previously operated patients
intervention type: Other
intervention name: Questionnaires
description: evaluating the voice outcome by the fullfilment of the voice handicap index
arm group label: Questionnaire
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Belgium
country: Spain
country: Mexico
responsible party type: Sponsor
mesh term: Vocal Cord Paralysis
mesh term: Paralysis