<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/NCT01669278</url>
  </required_header>
  <id_info>
    <org_study_id>UA-Endo001</org_study_id>
    <nct_id>NCT01669278</nct_id>
  </id_info>
  <brief_title>Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy</brief_title>
  <official_title>Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The processing of standard flexible nasopharyngoscopes is a time-consuming and costly&#xD;
      process. The goal of this study is to determine the efficiency and cost-effectiveness of&#xD;
      sheathed flexible endoscope in an office setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: Randomized, single-blinded, controlled trial&#xD;
&#xD;
      Setting: Office practice of two academic otolaryngologists at a community hospital.&#xD;
&#xD;
      Primary Outcomes: Patient pain and discomfort, Optical quality&#xD;
&#xD;
      Secondary Outcomes: Physician and nursing staff satisfaction&#xD;
&#xD;
      Cost-analysis&#xD;
&#xD;
      Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient pain and discomfort</measure>
    <time_frame>1 hour</time_frame>
    <description>Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician and staff satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>Physician and support staff satisfaction with easy and efficiency of sheathed scopes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical quality</measure>
    <time_frame>1 hour</time_frame>
    <description>Image quality of flexible endoscopy with or without endosheath.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Otorhinolaryngologic Diseases</condition>
  <arm_group>
    <arm_group_label>Traditional flexible nasopharyngolaryngoscopy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No sheath procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sheath flexible nasopharyngolaryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flexible nasopharyngolaryngoscopy using endosheath</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endosheath</intervention_name>
    <description>Flexible sheathed nasopharyngolaryngoscopy</description>
    <arm_group_label>Sheath flexible nasopharyngolaryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with&#xD;
             complaints warranting flexible endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sinonasal masses or nasal polyposis&#xD;
&#xD;
          -  Unable to complete VAS surveys&#xD;
&#xD;
          -  Significant septal deviation&#xD;
&#xD;
          -  Unable to tolerate in-office flexible nasopharyngoscopy&#xD;
&#xD;
          -  Patients who refuse consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Allan Ho</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6H 2H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sheath</keyword>
  <keyword>flexible</keyword>
  <keyword>endoscopy</keyword>
  <keyword>otolaryngology</keyword>
  <keyword>office</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Otorhinolaryngologic Diseases</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/NCT01669278
org study id: UA-Endo001
nct id: NCT01669278
lead sponsor: 
has dmc: No
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly
      process. The goal of this study is to determine the efficiency and cost-effectiveness of
      sheathed flexible endoscope in an office setting.
Methods: Randomized, single-blinded, controlled trial

      Setting: Office practice of two academic otolaryngologists at a community hospital.

      Primary Outcomes: Patient pain and discomfort, Optical quality

      Secondary Outcomes: Physician and nursing staff satisfaction

      Cost-analysis

      Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Patient pain and discomfort
time frame: 1 hour
description: Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale
measure: Physician and staff satisfaction
time frame: 1 week
description: Physician and support staff satisfaction with easy and efficiency of sheathed scopes.
measure: Optical quality
time frame: 1 hour
description: Image quality of flexible endoscopy with or without endosheath.
arm group label: Traditional flexible nasopharyngolaryngoscopy
arm group type: No Intervention
description: No sheath procedure
arm group label: Sheath flexible nasopharyngolaryngoscopy
arm group type: Active Comparator
description: Flexible nasopharyngolaryngoscopy using endosheath
intervention type: Device
intervention name: Endosheath
description: Flexible sheathed nasopharyngolaryngoscopy
arm group label: Sheath flexible nasopharyngolaryngoscopy
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Allan Ho
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Otorhinolaryngologic Diseases