<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/NCT03807713</url>
  </required_header>
  <id_info>
    <org_study_id>C69</org_study_id>
    <nct_id>NCT03807713</nct_id>
  </id_info>
  <brief_title>Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration</brief_title>
  <official_title>Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration</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>
      The objective of the study is to compare the outcomes after a surgical procedure with&#xD;
      minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control)&#xD;
      for placing Oticon Medical Ponto implants and abutments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2018</start_date>
  <completion_date type="Actual">March 29, 2022</completion_date>
  <primary_completion_date type="Actual">November 6, 2019</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>Numbness (sensibility) around the implant</measure>
    <time_frame>6 months post surgery</time_frame>
    <description>Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of surgery</measure>
    <time_frame>At surgery</time_frame>
    <description>Compare the surgical time between test (this investigation) and control group (previous investigation, C47).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned visits</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse skin reactions</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare the rate of adverse skin reactions using the Holgers Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse skin reactions</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare the rate of adverse skin reactions using the IPS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain perception by patient</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare pain using a visual analogue scale 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant survivability</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare implant survivability in terms of reported implant loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant stability as measured with resonance frequency analysis, RFA.</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare implant stability.&#xD;
Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical wound healing time</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare healing time after surgery.&#xD;
Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound dehiscence</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate wound dehiscence size after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare subjective benefit as measured by SSQ questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare subjective benefit as measured by YORK questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare subjective benefit as measured by APHAB questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare subjective benefit as measured by GBI questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare subjective benefit as measured by GHSI questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Bone Conduction Deafness</condition>
  <condition>Unilateral Deafness</condition>
  <condition>Middle Ear Deafness</condition>
  <condition>Mixed Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Minimally Invasive Ponto Surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Surgical method for installation of a bone anchored hearing system for hearing rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Minimally Invasive Ponto Surgery</intervention_name>
    <description>Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.</description>
    <arm_group_label>Minimally Invasive Ponto Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older.&#xD;
&#xD;
          -  Patient indicated for an ear level bone anchored sound processor.&#xD;
&#xD;
          -  Healthy bone quality to allow for 4mm implant insertion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraoperative switch to an alternative surgical technique&#xD;
&#xD;
          -  Patients undergoing re-implantation (on the side being included in the study)&#xD;
&#xD;
          -  Previous participation in the C47 study.&#xD;
&#xD;
          -  Inability to participate in follow-up.&#xD;
&#xD;
          -  Psychiatric disease in the medical history.&#xD;
&#xD;
          -  Mental disability.&#xD;
&#xD;
          -  Presumed doubt, for any reason, that the patient will be able to show up on all&#xD;
             follow-ups.&#xD;
&#xD;
          -  Diseases or treatments known to compromise the bone quality at the implant site, e.g.&#xD;
             radiotherapy, osteoporosis, diabetes mellitus.&#xD;
&#xD;
          -  Patients with natural skin height of &gt;12mm (as there will be additional skin reduction&#xD;
             needed)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myrthe Hol, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud UMC, Department of Otorhinolaryngology. The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</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>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Mixed Conductive-Sensorineural</mesh_term>
    <mesh_term>Hearing Loss, Unilateral</mesh_term>
    <mesh_term>Hearing Loss, Conductive</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/NCT03807713
org study id: C69
nct id: NCT03807713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to compare the outcomes after a surgical procedure with
      minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control)
      for placing Oticon Medical Ponto implants and abutments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numbness (sensibility) around the implant
time frame: 6 months post surgery
description: Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
measure: Length of surgery
time frame: At surgery
description: Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
measure: Unplanned visits
time frame: 36 months
description: Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).
measure: Adverse skin reactions
time frame: 36 months
description: Investigate and compare the rate of adverse skin reactions using the Holgers Scale.
measure: Adverse skin reactions
time frame: 36 months
description: Investigate and compare the rate of adverse skin reactions using the IPS scale.
measure: Pain perception by patient
time frame: 36 months
description: Investigate and compare pain using a visual analogue scale 0-10
measure: Implant survivability
time frame: 36 months
description: Investigate and compare implant survivability in terms of reported implant loss.
measure: Implant stability as measured with resonance frequency analysis, RFA.
time frame: 36 months
description: Investigate and compare implant stability.
Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).
measure: Surgical wound healing time
time frame: 36 months
description: Investigate and compare healing time after surgery.
Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing.
measure: Wound dehiscence
time frame: 36 months
description: Investigate wound dehiscence size after surgery.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by SSQ questionnaire.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by YORK questionnaire.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by APHAB questionnaire.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by GBI questionnaire.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by GHSI questionnaire.
arm group label: Minimally Invasive Ponto Surgery
arm group type: Other
description: Surgical method for installation of a bone anchored hearing system for hearing rehabilitation
intervention type: Device
intervention name: Minimally Invasive Ponto Surgery
description: Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
arm group label: Minimally Invasive Ponto Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Myrthe Hol, MD, PhD
role: Principal Investigator
affiliation: Radboud UMC, Department of Otorhinolaryngology. The Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Mixed Conductive-Sensorineural
mesh term: Hearing Loss, Unilateral
mesh term: Hearing Loss, Conductive
sharing ipd: No