<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/NCT03782545</url>
  </required_header>
  <id_info>
    <org_study_id>C-18-TS-18</org_study_id>
    <nct_id>NCT03782545</nct_id>
  </id_info>
  <brief_title>Multi-Center Pilot Study of Cutera truSculpt Device</brief_title>
  <official_title>Multi-Center Pilot Study of Cutera truSculpt Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutera Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cutera Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2018</start_date>
  <completion_date type="Actual">December 19, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2018</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>
    <intervention_model_description>A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an open label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>GAIS at 12 Weeks Post Final Treatment</measure>
    <time_frame>12 weeks post final treatment</time_frame>
    <description>Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change&#xD;
Mild Improvement&#xD;
Moderate improvement&#xD;
Significant Improvement</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Treatment for Cellulite on the Stomach and Flanks</condition>
  <arm_group>
    <arm_group_label>Treatment with the truSculpt RF device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be treated with the truSculpt RF device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cutera truSculpt Device</intervention_name>
    <description>The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.</description>
    <arm_group_label>Treatment with the truSculpt RF device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subject must be able to read, understand and sign the Informed Consent Form.&#xD;
&#xD;
             2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat&#xD;
             bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to&#xD;
             refrain from smoking for the duration of the study.&#xD;
&#xD;
             5. Subject must agree to not undergo any other procedure(s) in the treatment region&#xD;
             during the study period.&#xD;
&#xD;
             6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject&#xD;
             must adhere to the same diet and/or exercise routine throughout the study, and agree&#xD;
             to maintain the same weight throughout the study.&#xD;
&#xD;
             8. Willing to have photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentation, (educational and/or marketing), publications, and any&#xD;
             additional marketing purposes.&#xD;
&#xD;
             9. For female subjects: not pregnant or lactating and is either post-menopausal,&#xD;
             surgically sterilized, or using a medically acceptable form of birth control prior to&#xD;
             enrollment and during the entire course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical trial of another device or drug within 1 month of study&#xD;
             participation, or during the study period.&#xD;
&#xD;
          2. Any type of prior cosmetic treatment to the target area within 6 months of study&#xD;
             participation.&#xD;
&#xD;
          3. Any prior invasive cosmetic surgery to the target area, such as liposuction.&#xD;
&#xD;
          4. 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;
          5. Has metal implant(s) within the body, such as artificial heart valves.&#xD;
&#xD;
          6. Significant uncontrolled concurrent illness that in the opinion of the Investigator&#xD;
             would make the subject unsuitable for inclusion.&#xD;
&#xD;
          7. History of any disease or condition that could impair wound healing.&#xD;
&#xD;
          8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.&#xD;
&#xD;
          9. Skin abnormality in the treatment area that in the opinion of the Investigator would&#xD;
             make the subject unsuitable for inclusion.&#xD;
&#xD;
         10. 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;
         11. Allergy or sensitivity to Tegaderm.&#xD;
&#xD;
         12. 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 or a condition that would&#xD;
             compromise the subject's ability to comply with the study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laser and Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Dermatology</name>
      <address>
        <city>Glencoe</city>
        <state>Illinois</state>
        <zip>60022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Square Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>August 3, 2023</results_first_submitted>
  <results_first_submitted_qc>August 21, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Researchers involved in the study will have access to the final study data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03782545/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment With the truSculpt RF Device</title>
          <description>Subjects will be treated with the truSculpt RF device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </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>Treatment With the truSculpt RF Device</title>
          <description>Subjects will be treated with the truSculpt RF device</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </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="34"/>
                  </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="30"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>GAIS at 12 Weeks Post Final Treatment</title>
        <description>Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change&#xD;
Mild Improvement&#xD;
Moderate improvement&#xD;
Significant Improvement</description>
        <time_frame>12 weeks post final treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment With the truSculpt RF Device</title>
            <description>Subjects will be treated with the truSculpt RF device</description>
          </group>
        </group_list>
        <measure>
          <title>GAIS at 12 Weeks Post Final Treatment</title>
          <description>Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change&#xD;
Mild Improvement&#xD;
Moderate improvement&#xD;
Significant Improvement</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 12 weeks post final treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment With the truSculpt RF Device</title>
          <description>Subjects will be treated with the truSculpt 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="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </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="22" subjects_at_risk="34"/>
              </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="22" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </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>415-656-9612</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/NCT03782545
org study id: C-18-TS-18
nct id: NCT03782545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
primary purpose: Treatment
masking: None (Open Label)
masking description: This is an open label study.
measure: GAIS at 12 Weeks Post Final Treatment
time frame: 12 weeks post final treatment
description: Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change
Mild Improvement
Moderate improvement
Significant Improvement
arm group label: Treatment with the truSculpt RF device
arm group type: Experimental
description: Subjects will be treated with the truSculpt RF device
intervention type: Device
intervention name: Cutera truSculpt Device
description: The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
arm group label: Treatment with the truSculpt RF device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cellulite
sharing ipd: Yes
ipd description: Researchers involved in the study will have access to the final study data.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 