<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/NCT03018587</url>
  </required_header>
  <id_info>
    <org_study_id>C-16-TS12</org_study_id>
    <nct_id>NCT03018587</nct_id>
  </id_info>
  <brief_title>Feasibility Study of the TruSculpt Radiofrequency Device</brief_title>
  <official_title>Feasibility Study of the TruSculpt Radiofrequency Device</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>
      A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency&#xD;
      device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single-center, prospective, open-label study to evaluate the safety and efficacy of the&#xD;
      Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 29, 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Investigator Assessment of Improvement</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (&gt;75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (&lt;5%)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Tissue Tightening</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive 1 truSculpt radiofrequency treatment in desired area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TruSculpt</intervention_name>
    <description>All subjects will receive 1 truSculpt radiofrequency treatment</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female, 18 to 70 years of age (inclusive)&#xD;
&#xD;
          2. Fitzpatrick Skin Type I - VI&#xD;
&#xD;
          3. Has visible fat bulges,skin laxity, or cellulite in the treatment area&#xD;
&#xD;
          4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration&#xD;
             of the study.&#xD;
&#xD;
          5. Subject must agree to not undergo any other procedure(s) in the treatment area during&#xD;
             the study period.&#xD;
&#xD;
          6. Subject must be able to read, understand and sign the Informed Consent Form.&#xD;
&#xD;
          7. Subject must adhere to the follow-up schedule and study instructions.&#xD;
&#xD;
          8. Willing to have digital photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentation, educational or marketing purposes.&#xD;
&#xD;
          9. Post-menopausal or surgically sterilized, or using a medically acceptable form of&#xD;
             birth control at least 3 months prior to enrollment and during the entire course of&#xD;
             the study, and no plans to become pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical trial of another device or drug in the target area during&#xD;
             the study period.&#xD;
&#xD;
          2. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve&#xD;
             stimulator implant, cochlear implant or any other electronically, magnetically or&#xD;
             mechanically activated implant.&#xD;
&#xD;
          3. Has metal implant(s) within the body that is local to the treatment area, such as&#xD;
             surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves&#xD;
             or artificial joints.&#xD;
&#xD;
          4. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease,&#xD;
             peripheral vascular disease or pertinent neurological disorders.&#xD;
&#xD;
          5. Diagnosed or documented immune system disorders.&#xD;
&#xD;
          6. History of any disease or condition that could impair wound healing.&#xD;
&#xD;
          7. History of diseases stimulated by heat, such as recurrent herpes zoster in the&#xD;
             treatment area, unless treatment is conducted following a prophylactic regimen.&#xD;
&#xD;
          8. Infection, dermatitis, rash or other skin abnormality in the target area.&#xD;
&#xD;
          9. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or&#xD;
             history of treatment in the target area within 3 months of study participation.&#xD;
&#xD;
         10. Pregnant or currently breastfeeding.&#xD;
&#xD;
         11. As per the Investigator's discretion, any physical or mental condition which might&#xD;
             make it unsafe for the subject to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Ronan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>February 9, 2023</results_first_submitted>
  <results_first_submitted_qc>February 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2023</results_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>None. No individual participant data will be shared with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03018587/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Subjects</title>
          <description>All subjects will receive 1 truSculpt radiofrequency treatment in desired area.&#xD;
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>All subjects will receive 1 truSculpt radiofrequency treatment in desired area.&#xD;
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </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="23"/>
                  </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="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visible fat bulges, skin laxity, or cellulite</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator Assessment of Improvement</title>
        <description>Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (&gt;75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (&lt;5%)</description>
        <time_frame>12 weeks post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>All subjects will receive 1 truSculpt radiofrequency treatment in desired area.&#xD;
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Assessment of Improvement</title>
          <description>Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (&gt;75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (&lt;5%)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Subjects</title>
          <description>All subjects will receive 1 truSculpt radiofrequency treatment in desired area.&#xD;
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment</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="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
              </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="23" subjects_at_risk="23"/>
              </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="21" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nodules</sub_title>
                <description>Palpable firm lumps within subcutaneous fat developing 2-3 days after radiofrequency treatment in some areas treated which self-resolve typically within 4 to 8 weeks without intervention</description>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Post treatment pain/discomfort</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
              </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, Inc.</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/NCT03018587
org study id: C-16-TS12
nct id: NCT03018587
lead sponsor: 
is fda regulated device: Yes
A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency
      device.
A single-center, prospective, open-label study to evaluate the safety and efficacy of the
      Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator Assessment of Improvement
time frame: 12 weeks post-treatment
description: Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (<5%)
arm group label: All subjects
arm group type: Experimental
description: All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
intervention type: Device
intervention name: TruSculpt
description: All subjects will receive 1 truSculpt radiofrequency treatment
arm group label: All subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Ronan, M.D.
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: None. No individual participant data will be shared with other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 