<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/NCT03281967</url>
  </required_header>
  <id_info>
    <org_study_id>C63</org_study_id>
    <nct_id>NCT03281967</nct_id>
  </id_info>
  <brief_title>Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)</brief_title>
  <official_title>Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)</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">June 9, 2017</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</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 surgery area</measure>
    <time_frame>6 months post surgery</time_frame>
    <description>The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments.&#xD;
Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time needed for 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 visit</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare the number of unplanned visits, unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain perception by patient</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare patient perceived pain.&#xD;
For pain measurement, the patient is asked if pain around the implant is present. If it's present, duration is assessed (more or less than 6 weeks present). In addition, increase of pain is assessed during manipulation of the abutment (tightening of or tapping on the abutment). The patient is asked to score the perceived pain on a scale of 0-10; with 0 being no pain at all and 10 being the highest pain the patient had ever experienced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant survivability</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare implant survivability.&#xD;
Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant stability as measures by Implant stability quotient.</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate implant stability.</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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.</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, GBI and GHSI questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic Assessment</measure>
    <time_frame>36 months</time_frame>
    <description>Investigate and compare scar assessment by surgeon and patient (POSAS).</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 Implant in patients indicated and counselled for Bone Anchored Hearing System.</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>University Medical Center St Radboud</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</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/NCT03281967
org study id: C63
nct id: NCT03281967
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 surgery area
time frame: 6 months post surgery
description: The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments.
Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.
measure: Time needed for surgery
time frame: At surgery
description: Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
measure: Unplanned visit
time frame: 36 months
description: Investigate and compare the number of unplanned visits, unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).
measure: Adverse Events
time frame: 36 months
description: Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.
measure: Pain perception by patient
time frame: 36 months
description: Investigate and compare patient perceived pain.
For pain measurement, the patient is asked if pain around the implant is present. If it's present, duration is assessed (more or less than 6 weeks present). In addition, increase of pain is assessed during manipulation of the abutment (tightening of or tapping on the abutment). The patient is asked to score the perceived pain on a scale of 0-10; with 0 being no pain at all and 10 being the highest pain the patient had ever experienced.
measure: Implant survivability
time frame: 36 months
description: Investigate and compare implant survivability.
Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.
measure: Implant stability as measures by Implant stability quotient.
time frame: 36 months
description: Investigate implant stability.
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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.
measure: Quality of Life Assessment
time frame: 36 months
description: Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.
measure: Aesthetic Assessment
time frame: 36 months
description: Investigate and compare scar assessment by surgeon and patient (POSAS).
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 Implant in patients indicated and counselled for Bone Anchored Hearing System.
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