<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/NCT02262247</url>
  </required_header>
  <id_info>
    <org_study_id>FLX-ENT-PMK-OUS-001</org_study_id>
    <nct_id>NCT02262247</nct_id>
  </id_info>
  <brief_title>A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures</brief_title>
  <official_title>A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medrobotics Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medrobotics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic&#xD;
      System to visualize and access specific anatomical locations along with evaluation of the&#xD;
      safety of the device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Access and Visualizaton in Oropharynx, Hypopharynx and Larynx</measure>
    <time_frame>Intra-Operative</time_frame>
    <description>Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>OSA</condition>
  <condition>Oral Disease</condition>
  <condition>Oropharyngeal Neoplasms</condition>
  <condition>Hypopharyngeal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Transoral Visualization &amp; Access</arm_group_label>
    <description>Subjects ≥ 22 yrs requiring transoral procedures</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects ≥ 22 years of age requiring transoral procedures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 22 years of age&#xD;
&#xD;
          -  Candidate for transoral surgery in the oropharynx, hypopharynx and larynx&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 22 years of age&#xD;
&#xD;
          -  Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D Tricoli, BS, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Medrobotics Corp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Louvain at Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hosptial Giessen and Marburg</name>
      <address>
        <city>Marburg</city>
        <state>Baldingerstraße</state>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Essen</name>
      <address>
        <city>Essen</city>
        <state>Hufelandstraße</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>March 14, 2016</last_update_submitted>
  <last_update_submitted_qc>March 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transoral</keyword>
  <keyword>Oropharynx</keyword>
  <keyword>Hypopharynx</keyword>
  <keyword>Endoscopic</keyword>
  <keyword>TORS</keyword>
  <keyword>Endoscopic Transoral</keyword>
  <keyword>Larynx</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Hypopharyngeal Neoplasms</mesh_term>
    <mesh_term>Mouth Diseases</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/NCT02262247
org study id: FLX-ENT-PMK-OUS-001
nct id: NCT02262247
lead sponsor: 
has dmc: No
The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic
      System to visualize and access specific anatomical locations along with evaluation of the
      safety of the device.
observational model: Case-Only
time perspective: Prospective
measure: Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
time frame: Intra-Operative
description: Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.
arm group label: Transoral Visualization & Access
description: Subjects ≥ 22 yrs requiring transoral procedures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael D Tricoli, BS, MBA
role: Study Director
affiliation: Medrobotics Corp
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Oropharyngeal Neoplasms
mesh term: Hypopharyngeal Neoplasms
mesh term: Mouth Diseases
sharing ipd: No