<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/NCT01727544</url>
  </required_header>
  <id_info>
    <org_study_id>12-001953</org_study_id>
    <nct_id>NCT01727544</nct_id>
  </id_info>
  <brief_title>Vestibular Function Outcome After Cartilage Cap Occlusion Surgery</brief_title>
  <official_title>Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to measure objective, functional outcomes of patients&#xD;
      undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One option for managing a dehiscent superior semicircular canal is surgical intervention. One&#xD;
      of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap&#xD;
      occlusion of the dehiscent superior semicircular canal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Changed to a retrospective chart review&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective improvement</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>The primary outcome measure will be the subsequent (3 month) FGA scores between the control group and the surgery group to assess any objective improvement attributable to surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ABC Scale</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS scores</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vestibular Dizziness</condition>
  <condition>Superior Semicircular Canal Dehiscence</condition>
  <arm_group>
    <arm_group_label>Surgical Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Surgical Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients meet the same criteria but will elect not to undergo surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cartilage cap occlusion surgery</intervention_name>
    <description>placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.</description>
    <arm_group_label>Surgical Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ambulatory&#xD;
&#xD;
          -  independent self-sufficient adults&#xD;
&#xD;
          -  good general health&#xD;
&#xD;
          -  medically stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry Lundy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>February 11, 2014</last_update_submitted>
  <last_update_submitted_qc>February 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Larry B. Lundy</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>superior semicircular canal</keyword>
  <keyword>non-vestibular dizziness</keyword>
  <keyword>vestibular dizziness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Semicircular Canal Dehiscence</mesh_term>
    <mesh_term>Dizziness</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/NCT01727544
org study id: 12-001953
nct id: NCT01727544
lead sponsor: 
has dmc: No
The primary objective of this study is to measure objective, functional outcomes of patients
      undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.
One option for managing a dehiscent superior semicircular canal is surgical intervention. One
      of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap
      occlusion of the dehiscent superior semicircular canal.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: objective improvement
time frame: baseline to 3 months
description: The primary outcome measure will be the subsequent (3 month) FGA scores between the control group and the surgery group to assess any objective improvement attributable to surgery
measure: ABC Scale
time frame: baseline to 3 months
description: Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.
measure: VAS scores
time frame: baseline to 3 months
description: Secondary objective outcome measures will be changes in conductive hearing loss and changes in cervical VEMP thresholds between the two groups at the 3-month interval. Secondary subjective outcome measures will be ABC Scale and VAS scores between the two groups at 3 months.
arm group label: Surgical Group
arm group type: Active Comparator
description: patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
arm group label: Non Surgical Group
arm group type: No Intervention
description: patients meet the same criteria but will elect not to undergo surgery
intervention type: Procedure
intervention name: cartilage cap occlusion surgery
description: placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.
arm group label: Surgical Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Larry Lundy, MD
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Larry B. Lundy
investigator title: PI
mesh term: Vertigo
mesh term: Semicircular Canal Dehiscence
mesh term: Dizziness