<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/NCT03297736</url>
  </required_header>
  <id_info>
    <org_study_id>3D CAD/CAM</org_study_id>
    <nct_id>NCT03297736</nct_id>
  </id_info>
  <brief_title>Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts</brief_title>
  <official_title>Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nitinetics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nitinetics LLC</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>
      Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment.&#xD;
      Study participants, requiring middle ear surgery and ossicular reconstruction, will be&#xD;
      implanted with one of two middle ear implants. The rationale is to complete a pilot study of&#xD;
      the technology with a small number of designs. Each implant will be commonly used, in the&#xD;
      public domain, and recreated by the CAD/CAM software.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional middle ear prosthetic prosthetics, including total ossicular replacement&#xD;
      prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive,&#xD;
      require large inventories for otologic surgery services, and carry the risk of extrusion or&#xD;
      rejection. Autologous bone and cartilage can be used for many of these applications, but it&#xD;
      requires expensive operating room time for carving to the appropriate shape and size.&#xD;
&#xD;
      The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted&#xD;
      design/computer assisted manufacture) to produce accurate bone and cartilage autografts on&#xD;
      demand in the operating room. Such a technology is hypothesized to save money by reducing&#xD;
      operating room time, and reducing the need for expensive inventories of various shapes,&#xD;
      sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be&#xD;
      less likely to extrude or cause other problems such as infection, this could also reduce&#xD;
      costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</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>Device Feasibility</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cost savings</measure>
    <time_frame>perioperative</time_frame>
    <description>operative costs compared between treatment groups utilizing total operative time in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>6 months</time_frame>
    <description>infectious process involving the use of a medical device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABG</measure>
    <time_frame>preoperative; 6weeks, 3 months, and 6 months postoperatively.</time_frame>
    <description>mean air-bone gap assessed and compared between treatment groups for statistical significance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that experience device rejection</measure>
    <time_frame>6 months</time_frame>
    <description>rejection of device/prosthesis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Middle Ear Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive the control device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject receives the 3D CAD/CAM autograft prosthesis implant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D CAD/CAM autograft prosthesis</intervention_name>
    <description>Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.</description>
    <arm_group_label>Investigational device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control device</intervention_name>
    <description>Surgical ossicular reconstruction with the standard available middle ear prosthesis.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years of age with middle ear disease requiring surgical ossicular&#xD;
             reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital anomalies&#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>Glenn Knox, M.D., J.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nitinetics LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Glenn Knox, M.D., J.D.</last_name>
    <phone>(904) 244-3498</phone>
    <email>Glenn.Knox@jax.ufl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alisa Knox</last_name>
    <email>alisa102189@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Florida-Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Glenn Knox, M.D., J.D.</last_name>
      <phone>904-244-3498</phone>
      <email>Glenn.Knox@jax.ufl.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</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>Ear Diseases</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/NCT03297736
org study id: 3D CAD/CAM
nct id: NCT03297736
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment.
      Study participants, requiring middle ear surgery and ossicular reconstruction, will be
      implanted with one of two middle ear implants. The rationale is to complete a pilot study of
      the technology with a small number of designs. Each implant will be commonly used, in the
      public domain, and recreated by the CAD/CAM software.
Conventional middle ear prosthetic prosthetics, including total ossicular replacement
      prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive,
      require large inventories for otologic surgery services, and carry the risk of extrusion or
      rejection. Autologous bone and cartilage can be used for many of these applications, but it
      requires expensive operating room time for carving to the appropriate shape and size.

      The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted
      design/computer assisted manufacture) to produce accurate bone and cartilage autografts on
      demand in the operating room. Such a technology is hypothesized to save money by reducing
      operating room time, and reducing the need for expensive inventories of various shapes,
      sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be
      less likely to extrude or cause other problems such as infection, this could also reduce
      costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Single (Participant)
measure: Cost savings
time frame: perioperative
description: operative costs compared between treatment groups utilizing total operative time in minutes
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0
time frame: 6 months
description: infectious process involving the use of a medical device
measure: ABG
time frame: preoperative; 6weeks, 3 months, and 6 months postoperatively.
description: mean air-bone gap assessed and compared between treatment groups for statistical significance
measure: Number of participants that experience device rejection
time frame: 6 months
description: rejection of device/prosthesis
arm group label: Control
arm group type: Active Comparator
description: Subjects receive the control device.
arm group label: Investigational device
arm group type: Experimental
description: Subject receives the 3D CAD/CAM autograft prosthesis implant.
intervention type: Device
intervention name: 3D CAD/CAM autograft prosthesis
description: Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
arm group label: Investigational device
intervention type: Device
intervention name: Control device
description: Surgical ossicular reconstruction with the standard available middle ear prosthesis.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Glenn Knox, M.D., J.D.
role: Principal Investigator
affiliation: Nitinetics LLC
last name: Glenn Knox, M.D., J.D.
phone: (904) 244-3498
email: Glenn.Knox@jax.ufl.edu
last name: Alisa Knox
email: alisa102189@yahoo.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Ear Diseases