<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/NCT01708434</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-115</org_study_id>
    <nct_id>NCT01708434</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulthera, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merz North America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30&#xD;
      subjects will be enrolled. Study photos will be obtained prior to study treatment,&#xD;
      immediately following study treatment, and at each post-treatment follow-up visit. Follow-up&#xD;
      visits will occur at 90 and 180 days post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a prospective, single-center clinical trial of the Ulthera® System for&#xD;
      treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient&#xD;
      Satisfaction questionnaires will be obtained at each follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Improvement in overall lifting and tightening of knee skin laxity.</measure>
    <time_frame>90 and 180 days post-treatment</time_frame>
    <description>Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall improvement in skin laxity.</measure>
    <time_frame>90 and 180 days post-treatment</time_frame>
    <description>Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Ulthera® treatment of the knees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral treatment of the knees using the Ulthera® System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera® System</intervention_name>
    <description>Focused ultrasound energy delivered below the surface of the skin</description>
    <arm_group_label>Ulthera® treatment of the knees</arm_group_label>
    <other_name>Ultherapy™ treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, aged 30 to 65 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Mild to moderate skin laxity around the knees.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             areas to be treated through the follow-up period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  Excessive subcutaneous fat around the knees.&#xD;
&#xD;
          -  Excessive skin laxity around the knees.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Gold, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tennessee Clinical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>November 21, 2017</last_update_submitted>
  <last_update_submitted_qc>November 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin laxity</keyword>
  <keyword>Knees</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cutis Laxa</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/NCT01708434
org study id: ULT-115
nct id: NCT01708434
lead sponsor: 
has dmc: No
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30
      subjects will be enrolled. Study photos will be obtained prior to study treatment,
      immediately following study treatment, and at each post-treatment follow-up visit. Follow-up
      visits will occur at 90 and 180 days post-treatment.
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for
      treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient
      Satisfaction questionnaires will be obtained at each follow-up visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in overall lifting and tightening of knee skin laxity.
time frame: 90 and 180 days post-treatment
description: Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
measure: Overall improvement in skin laxity.
time frame: 90 and 180 days post-treatment
description: Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.
arm group label: Ulthera® treatment of the knees
arm group type: Experimental
description: Bilateral treatment of the knees using the Ulthera® System
intervention type: Device
intervention name: Ulthera® System
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Ulthera® treatment of the knees
other name: Ultherapy™ treatment
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Gold, MD
role: Principal Investigator
affiliation: Tennessee Clinical Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa