<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/NCT03840070</url>
  </required_header>
  <id_info>
    <org_study_id>MT05-KR18PGE1005</org_study_id>
    <nct_id>NCT03840070</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement</brief_title>
  <official_title>A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study is for small-penis syndrome males who have previously been treated with&#xD;
      hyaluronic acid filler for the purpose of increasing their penis.&#xD;
&#xD;
      This study will determine the long-term efficacy and safety of Potenfill.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 17, 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>Subject satisfaction on the penile appearance at 12 months after application of Potenfill</measure>
    <time_frame>12 month</time_frame>
    <description>Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Penile Girth Enhancement</condition>
  <condition>Penile Enhancement</condition>
  <arm_group>
    <arm_group_label>Potenfill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Potenfill</intervention_name>
    <description>Maximum: 22ml</description>
    <arm_group_label>Potenfill</arm_group_label>
    <other_name>hyaluronic acid filler</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects aged above 19 and below 65. (20≤male≥65)&#xD;
&#xD;
          -  Subjects will sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment for penile enhancement (e.g. fat, dermal graft).&#xD;
&#xD;
          -  Allergic to hyalluronic acid.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea university guro hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03840070
org study id: MT05-KR18PGE1005
nct id: NCT03840070
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical study is for small-penis syndrome males who have previously been treated with
      hyaluronic acid filler for the purpose of increasing their penis.

      This study will determine the long-term efficacy and safety of Potenfill.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Subject satisfaction on the penile appearance at 12 months after application of Potenfill
time frame: 12 month
description: Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.
arm group label: Potenfill
arm group type: Experimental
intervention type: Device
intervention name: Potenfill
description: Maximum: 22ml
arm group label: Potenfill
other name: hyaluronic acid filler
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyaluronic Acid
sharing ipd: Undecided