<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/NCT01665118</url>
  </required_header>
  <id_info>
    <org_study_id>C-12-TS05</org_study_id>
    <nct_id>NCT01665118</nct_id>
  </id_info>
  <brief_title>The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction</brief_title>
  <official_title>The Cutera Trusculpt Device For Thigh Circumference Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutera Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cutera Inc.</source>
  <oversight_info>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio&#xD;
      Frequency) device in the reduction of thigh circumference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary efficacy variable for this study is the comparison of mean change in thigh&#xD;
      circumference from baseline to 12 weeks between two arms. The primary research hypothesis is&#xD;
      that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Thigh Circumference From Baseline</measure>
    <time_frame>Comparison of Baseline to 12 weeks post- final treatment</time_frame>
    <description>Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Body Fat</condition>
  <arm_group>
    <arm_group_label>Treated Thigh</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trusculpt (Radio Frequency) Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untreated Contra-lateral Thigh</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To be used as the self control in this split body study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trusculpt (Radio Frequency) Device</intervention_name>
    <arm_group_label>Treated Thigh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Non-smoking for at least 3 months and willing to refrain from smoking for the duration&#xD;
             of the study.&#xD;
&#xD;
          -  Post-menopausal, or on birth control and/or no plans to become pregnant for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 30&#xD;
&#xD;
          -  Visible fat in the thigh / saddlebag area to be treated&#xD;
&#xD;
          -  Subject must be able to read, understand and sign the Consent Form&#xD;
&#xD;
          -  Subject must adhere to the follow-up schedule and study instructions&#xD;
&#xD;
          -  Subject must adhere to the same diet and/or exercise routine throughout the study, and&#xD;
             agree to maintain the same weight throughout the study (within 6 lbs of the weight&#xD;
             measure at the baseline assessment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking weight-loss medications/supplements&#xD;
&#xD;
          -  Simultaneous participation in any other clinical study&#xD;
&#xD;
          -  Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty&#xD;
&#xD;
          -  Prior treatment to the target area within the last 12 months e.g., radio frequency or&#xD;
             cryolysis&#xD;
&#xD;
          -  Arteriosclerosis or weakened blood vessels&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  Thromboembolic disease&#xD;
&#xD;
          -  Diagnosed or documented immune system disorders (including Panniculitis)&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Presence of uncontrolled hypertension&#xD;
&#xD;
          -  Taking prescription anticoagulants&#xD;
&#xD;
          -  History of keloid formation&#xD;
&#xD;
          -  History of malignant tumors in the target area&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Any disease or condition that could impair wound healing&#xD;
&#xD;
          -  Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles&#xD;
&#xD;
          -  Infection in the target area&#xD;
&#xD;
          -  Implanted electrical device(s) or metallic implants&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Brian Biesman, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Barry DiBernardo, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Stephen Ronan, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Cutera Research Center</name>
      <address>
        <city>Brisbane</city>
        <state>California</state>
        <zip>94005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Plastic Surgery</name>
      <address>
        <city>Montclair</city>
        <state>New Jersey</state>
        <zip>07042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Center for Laser and Facial Surgery</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>September 28, 2022</results_first_submitted>
  <results_first_submitted_qc>January 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2023</results_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radio frequency</keyword>
  <keyword>thigh</keyword>
  <keyword>circumference</keyword>
  <keyword>reduction</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Thigh Treated With RF</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Untreated Thigh</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Enrolled Subjects</title>
          <description>Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of Thigh Circumference From Baseline</title>
        <description>Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.</description>
        <time_frame>Comparison of Baseline to 12 weeks post- final treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treated Thigh</title>
            <description>Treatment with Trusculpt (Radio Frequency) Device</description>
          </group>
          <group group_id="O2">
            <title>Contra-lateral Untreated Thigh</title>
            <description>No treatment with Trusculpt (Radio Frequency) Device</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Thigh Circumference From Baseline</title>
          <description>Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".98" lower_limit="-.30" upper_limit="2.05"/>
                    <measurement group_id="O2" value=".32" lower_limit="-.55" upper_limit="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks post final treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treated Thigh</title>
          <description>Trusculpt (Radio Frequency) Device</description>
        </group>
        <group group_id="E2">
          <title>Untreated Thigh</title>
          <description>No Treatment with RF device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Lumps</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Margot Doucette</name_or_title>
      <organization>Cutera</organization>
      <phone>415-657-5518</phone>
      <email>mdoucette@cutera.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01665118
org study id: C-12-TS05
nct id: NCT01665118
lead sponsor: 
is fda regulated device: Yes
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio
      Frequency) device in the reduction of thigh circumference.
The primary efficacy variable for this study is the comparison of mean change in thigh
      circumference from baseline to 12 weeks between two arms. The primary research hypothesis is
      that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Thigh Circumference From Baseline
time frame: Comparison of Baseline to 12 weeks post- final treatment
description: Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
arm group label: Treated Thigh
arm group type: Experimental
description: Trusculpt (Radio Frequency) Device
arm group label: Untreated Contra-lateral Thigh
arm group type: No Intervention
description: To be used as the self control in this split body study.
intervention type: Device
intervention name: Trusculpt (Radio Frequency) Device
arm group label: Treated Thigh
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brian Biesman, MD
role: Principal Investigator
last name: Barry DiBernardo, MD
role: Principal Investigator
last name: Stephen Ronan, MD
role: Principal Investigator
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 