<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/NCT03289845</url>
  </required_header>
  <id_info>
    <org_study_id>C55</org_study_id>
    <nct_id>NCT03289845</nct_id>
  </id_info>
  <brief_title>Clinical Survey of Oticon Medical Ponto BHX Implant</brief_title>
  <official_title>Clinical Survey of Oticon Medical Ponto BHX Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oticon Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oticon Medical</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>
      Investigation of stability of the BHX implant in adult patients indicated and counselled for&#xD;
      a bone anchored hearing aid system. Patients are followed according to clinical practice for&#xD;
      a total of 12 months in the study. Stability of the implant is evaluated by implant stability&#xD;
      quotient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">January 4, 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant stability quotient (ISQ) at surgery</measure>
    <time_frame>At surgery</time_frame>
    <description>Initial implant stability measured directly after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical torque setting measured in Ncm</measure>
    <time_frame>At surgery</time_frame>
    <description>The surgical torque setting used to install the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possibility to fit the sound processor, yes/no</measure>
    <time_frame>5-12 days post surgery</time_frame>
    <description>Fitting of the sound processor at 5-12 days post-surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant stability quotient (ISQ) after 12 months of follow up</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>Long term stability development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant survivability measured as percentage successful implants after 12 months</measure>
    <time_frame>12 months post surgery</time_frame>
    <description>Implant survivability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Hearing Impaired (Partially)</condition>
  <condition>Hearing Impairment, Conductive</condition>
  <condition>Deafness Unilateral</condition>
  <arm_group>
    <arm_group_label>BHX implant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients implanted with BHX implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BHX implant (Bone anchored hearing system)</intervention_name>
    <description>Bone anchored hearing system for hearing rehabilitation</description>
    <arm_group_label>BHX implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients eligible for treatment with a bone anchored hearing aid&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to participate in follow-up&#xD;
&#xD;
          -  Diseases or treatments known to compromise the bone quality at the implant site, e.g.&#xD;
             radiotherapy, osteoporosis, diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Otolaryngology - Head &amp; Neck Surgery and Audiology, Gentofte/Rigshospitalet,</name>
      <address>
        <city>Hellerup</city>
        <state>Copenhagen</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Oto-Rhino-Laryngology &amp; Audiology Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 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>Deafness</mesh_term>
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
    <mesh_term>Hearing Loss, Unilateral</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/NCT03289845
org study id: C55
nct id: NCT03289845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of stability of the BHX implant in adult patients indicated and counselled for
      a bone anchored hearing aid system. Patients are followed according to clinical practice for
      a total of 12 months in the study. Stability of the implant is evaluated by implant stability
      quotient.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implant stability quotient (ISQ) at surgery
time frame: At surgery
description: Initial implant stability measured directly after surgery
measure: Surgical torque setting measured in Ncm
time frame: At surgery
description: The surgical torque setting used to install the implant
measure: Possibility to fit the sound processor, yes/no
time frame: 5-12 days post surgery
description: Fitting of the sound processor at 5-12 days post-surgery
measure: Implant stability quotient (ISQ) after 12 months of follow up
time frame: 12 months post surgery
description: Long term stability development
measure: Implant survivability measured as percentage successful implants after 12 months
time frame: 12 months post surgery
description: Implant survivability
arm group label: BHX implant
arm group type: Other
description: All patients implanted with BHX implant
intervention type: Device
intervention name: BHX implant (Bone anchored hearing system)
description: Bone anchored hearing system for hearing rehabilitation
arm group label: BHX implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Deafness
mesh term: Hearing Loss
mesh term: Hearing Loss, Conductive
mesh term: Hearing Loss, Unilateral
sharing ipd: No