<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/NCT01695967</url>
  </required_header>
  <id_info>
    <org_study_id>version 3 03Mar2012</org_study_id>
    <nct_id>NCT01695967</nct_id>
  </id_info>
  <brief_title>Turbinate Cauterization in Pediatric Patients With Nasal Obstruction</brief_title>
  <official_title>Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Virginia Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to&#xD;
      reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and&#xD;
      tonsillectomy. It will compare the amount of nasal congestion for each group with the idea&#xD;
      that it will be less if treated with turbinate cauterization. Assessments from baseline to 6&#xD;
      months post procedure will be compared between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess if inferior turbinate cautery improves nasal obstruction in children undergoing&#xD;
      adenotonsillectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure># of participants with improved nasal obstruction score from baseline to 6 months</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Sleep Apnea</condition>
  <condition>Nasal Obstruction</condition>
  <arm_group>
    <arm_group_label>Turbinate Cauterization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Turbinate Cauterization will be completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no turbinate cauterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>turbinate cauterization</intervention_name>
    <arm_group_label>Turbinate Cauterization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 3-16&#xD;
&#xD;
          -  obstructive sleep apnea warranting adenotonsillectomy&#xD;
&#xD;
          -  history of daytime nasal obstruction and or mouth breathing&#xD;
&#xD;
          -  failed medical treatment with either oral anti-histamine or nasal steroid spray.&#xD;
&#xD;
          -  turbinate hypertrophy on Physical Exam defined by &gt;50% obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;3 or &gt;16&#xD;
&#xD;
          -  unwillingness to comply with study procedures&#xD;
&#xD;
          -  congenital head and neck malformations, genetic syndromes, craniofacial anomalies&#xD;
&#xD;
          -  no evidence of turbinate hypertrophy or symptoms of nasal obstruction&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  current therapy with coumadin or Pradaxa&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Baldassari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Virginia Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eastern Virginia Medical School</investigator_affiliation>
    <investigator_full_name>Cristina Baldassari M.D.</investigator_full_name>
    <investigator_title>Assistant Professor, Pediatric Otolaryngology</investigator_title>
  </responsible_party>
  <keyword>nasal obstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasal Obstruction</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/NCT01695967
org study id: version 3 03Mar2012
nct id: NCT01695967
lead sponsor: 
has dmc: No
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to
      reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and
      tonsillectomy. It will compare the amount of nasal congestion for each group with the idea
      that it will be less if treated with turbinate cauterization. Assessments from baseline to 6
      months post procedure will be compared between the two groups.
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing
      adenotonsillectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: # of participants with improved nasal obstruction score from baseline to 6 months
time frame: baseline and 6 months
description: Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.
arm group label: Turbinate Cauterization
arm group type: Experimental
description: Turbinate Cauterization will be completed.
arm group label: control
arm group type: No Intervention
description: no turbinate cauterization
intervention type: Procedure
intervention name: turbinate cauterization
arm group label: Turbinate Cauterization
criteria: 
gender: All
minimum age: 3 Years
maximum age: 16 Years
healthy volunteers: No
last name: Christina Baldassari, MD
role: Principal Investigator
affiliation: Eastern Virginia Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Eastern Virginia Medical School
investigator full name: Cristina Baldassari M.D.
investigator title: Assistant Professor, Pediatric Otolaryngology
mesh term: Nasal Obstruction