<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/NCT04496427</url>
  </required_header>
  <id_info>
    <org_study_id>MT05-KR19PGE1101</org_study_id>
    <nct_id>NCT04496427</nct_id>
  </id_info>
  <brief_title>Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement</brief_title>
  <official_title>A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of 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>
    <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>
      This is an observational study to determine the efficacy and safety of Potenfill for&#xD;
      temporary penile enhancement.&#xD;
&#xD;
      The pivotal study of Potenfill has already been completed and this observational study&#xD;
      determines the long-term efficacy and safety for up to 24 months in subjects who have been&#xD;
      participated and treated in the pivotal study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline</measure>
    <time_frame>18 months</time_frame>
    <description>Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline</measure>
    <time_frame>24 months</time_frame>
    <description>Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).</description>
  </primary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>Penile Enhancement</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Males over 19 and under 65 who have participated in the previous clinical investigation&#xD;
        (pivotal) and were treated with the investigational medical device and completed all the&#xD;
        anticipated visits.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males over 19 and under 65 who have participated in the previous clinical&#xD;
             investigation (pivotal) and were treated with the investigational medical device and&#xD;
             completed all the anticipated visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received any procedures or surgeries (penile enhancement procedure,&#xD;
             HA filler, collagen, etc.) in the penile area from the time after the participation of&#xD;
             the previous clinical investigation (pivotal) and before the screening for this&#xD;
             clinical investigation.&#xD;
&#xD;
          -  Subjects deemed as ineligible to participate by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kangdong Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Gangdong-gu</state>
        <zip>05355</zip>
        <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>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04496427
org study id: MT05-KR19PGE1101
nct id: NCT04496427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study to determine the efficacy and safety of Potenfill for
      temporary penile enhancement.

      The pivotal study of Potenfill has already been completed and this observational study
      determines the long-term efficacy and safety for up to 24 months in subjects who have been
      participated and treated in the pivotal study.
observational model: Other
time perspective: Prospective
measure: Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline
time frame: 18 months
description: Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
measure: Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline
time frame: 24 months
description: Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor