<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/NCT02999763</url>
  </required_header>
  <id_info>
    <org_study_id>DHF22621</org_study_id>
    <nct_id>NCT02999763</nct_id>
  </id_info>
  <brief_title>SlimShape Device for Abdominal Fat and Circumference Reduction</brief_title>
  <official_title>Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syneron Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Syneron Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape&#xD;
      device for non-invasive abdominal fat and circumference reduction.&#xD;
&#xD;
      Study subjects will undergo SlimShape treatments on the abdominal area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this trial is to evaluate the safety and efficacy of the SlimShape device&#xD;
      utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference&#xD;
      reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval)&#xD;
      with the SlimShape device utilizing the SlimShape Applicator Belt according to the study&#xD;
      protocol.&#xD;
&#xD;
      The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and&#xD;
      12 weeks (12wk FU) after the last treatment.&#xD;
&#xD;
      Each subject will be enrolled for total expected study duration of up to 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">August 7, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fat Thickness at Final Follow-up Compared to Baseline</measure>
    <time_frame>Baseline and 12 weeks follow-up</time_frame>
    <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fat Thickness After Treatments Compared to Baseline</measure>
    <time_frame>Baseline and 4 and 8 weeks follow-up</time_frame>
    <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Abdominal Circumference After Treatments Compared to Baseline</measure>
    <time_frame>At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)</time_frame>
    <description>Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Treatments Where Participants Reported Having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; Response</measure>
    <time_frame>First, second and third treatments, Weeks 0 to 4</time_frame>
    <description>Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; )</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Abdominal fat reduction treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SlimShape</intervention_name>
    <description>SlimShape radiofrequency treatment to the abdomen</description>
    <arm_group_label>Abdominal fat reduction treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent to participate in the study.&#xD;
&#xD;
          2. Female and male subjects, ≥18 and ≤60 years of age at the time of enrollment&#xD;
&#xD;
          3. Fitzpatrick Skin Type I to VI&#xD;
&#xD;
          4. BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).&#xD;
&#xD;
          5. If female, not pregnant, lactating and must be either post-menopausal, surgically&#xD;
             sterilized, or using a medically acceptable form of birth control at least 3 months&#xD;
             prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods&#xD;
             with spermicide or abstinence).&#xD;
&#xD;
          6. In addition, negative urine pregnancy test as tested before each treatment and at the&#xD;
             last visit for women with childbearing potential (e.g. not menopause).&#xD;
&#xD;
          7. General good health confirmed by medical history and skin examination of the treated&#xD;
             area.&#xD;
&#xD;
          8. Willing to follow the treatment and follow-up schedule and post-treatment care&#xD;
             instructions.&#xD;
&#xD;
          9. Willing to refrain from a change in diet/ exercise/medication regimen for the entire&#xD;
             course of the study.&#xD;
&#xD;
         10. Willing to have photographs and images taken of the treated areas to be used&#xD;
             de-identified in evaluations, publications and presentations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hypertension, ischemic heart disease, valvular heart disease, congestive&#xD;
             heart failure, pacemaker/defibrillator, abdominal aortic aneurism&#xD;
&#xD;
          2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive&#xD;
             status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue&#xD;
             disease&#xD;
&#xD;
          3. Having or undergoing any form of treatment for active cancer, or having a history of&#xD;
             skin cancer or any other cancer in the areas to be treated, including presence of&#xD;
             malignant or pre-malignant pigmented lesions&#xD;
&#xD;
          4. Having any active electrical implant anywhere in the body, such as a pacemaker or an&#xD;
             internal defibrillator&#xD;
&#xD;
          5. Having a permanent implant in the treated area, such as metal plates or an injected&#xD;
             chemical substance such as silicone&#xD;
&#xD;
          6. Having undergone any other surgery in the treated areas within 12 months of treatment&#xD;
             or during the study, including liposuction&#xD;
&#xD;
          7. Previous body contouring procedures in the treatment area within 12 months&#xD;
&#xD;
          8. History of skin disease in the treatment area, known tendency to form keloids or poor&#xD;
             wound healing&#xD;
&#xD;
          9. History of epidermal or dermal disorders (particularly if involving collagen or&#xD;
             microvascularity)&#xD;
&#xD;
         10. Suffering from significant skin conditions in the treated areas or inflammatory skin&#xD;
             conditions, including, but not limited to, open lacerations or abrasions and active&#xD;
             cold sores or herpes sores prior to treatment (duration of resolution as per the&#xD;
             Investigator's discretion) or during the treatment course&#xD;
&#xD;
         11. Allergy to any component of the lotion (VelaSpray Ease) used in this study&#xD;
&#xD;
         12. Skin lesions in the treatment area other than simple nevi on physical examination&#xD;
             (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment&#xD;
             area&#xD;
&#xD;
         13. Very poor skin quality (i.e., severe laxity)&#xD;
&#xD;
         14. Abdominal wall diastasis or hernia on physical examination&#xD;
&#xD;
         15. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count&#xD;
             within the last 3 months&#xD;
&#xD;
         16. Obesity (BMI &gt; 30)&#xD;
&#xD;
         17. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic&#xD;
             condition which, in the opinion of the investigator, could interfere with the conduct&#xD;
             of the study&#xD;
&#xD;
         18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six&#xD;
             months)&#xD;
&#xD;
         19. Inability to comply with circumference measurement procedure (e.g., inability to hold&#xD;
             breath for the required duration).&#xD;
&#xD;
         20. Participation in another clinical study involving same anatomical areas within the&#xD;
             last 6 months (or 30 days in case different anatomical areas were treated in previous&#xD;
             trial/s).&#xD;
&#xD;
         21. 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>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruthie Amir, MD</last_name>
    <role>Study Director</role>
    <affiliation>Syneron Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Medical Group, Inc</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syneron Candela Institute for Education Clinic</name>
      <address>
        <city>Wayland</city>
        <state>Massachusetts</state>
        <zip>01778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Square Laser Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Adatto MA, Adatto-Neilson RM, Morren G. Reduction in adipose tissue volume using a new high-power radiofrequency technology combined with infrared light and mechanical manipulation for body contouring. Lasers Med Sci. 2014 Sep;29(5):1627-31. doi: 10.1007/s10103-014-1564-x. Epub 2014 Apr 1.</citation>
    <PMID>24687404</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>March 14, 2019</results_first_submitted>
  <results_first_submitted_qc>March 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2019</results_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lipolysis</keyword>
  <keyword>fat reduction</keyword>
  <keyword>circumference reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>October 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02999763/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treated and Untreated Abdomen</title>
          <description>Circumference and fat thickness reduction of abdomen after SlimShape treatments (three treatments with SlimShape RF based 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="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treated and Untreated Abdomen</title>
          <description>Circumference and fat thickness measurements of abdomen before after SlimShape treatments of the same subjects</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
          </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="70"/>
                  </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>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="9.6"/>
                  </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="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </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="1"/>
                  </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="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fat Thickness</title>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.83" spread="7.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Circumference</title>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91.64" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Fat Thickness at Final Follow-up Compared to Baseline</title>
        <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline</description>
        <time_frame>Baseline and 12 weeks follow-up</time_frame>
        <population>58 participants analyzed at 12 week FU (12 subjects lost to follow-up at final visit)</population>
        <group_list>
          <group group_id="O1">
            <title>Treated Abdomen</title>
            <description>Subjects treated on the abdomen with SlimShape RF treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fat Thickness at Final Follow-up Compared to Baseline</title>
          <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline</description>
          <population>58 participants analyzed at 12 week FU (12 subjects lost to follow-up at final visit)</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.76" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fat Thickness After Treatments Compared to Baseline</title>
        <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline</description>
        <time_frame>Baseline and 4 and 8 weeks follow-up</time_frame>
        <population>63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit)</population>
        <group_list>
          <group group_id="O1">
            <title>Treated Abdomen</title>
            <description>Subjects treated on the abdomen with SlimShape RF treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fat Thickness After Treatments Compared to Baseline</title>
          <description>Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline</description>
          <population>63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit)</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fat thickness change at 4 week FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fat thickness change at 8 week FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Abdominal Circumference After Treatments Compared to Baseline</title>
        <description>Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline</description>
        <time_frame>At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)</time_frame>
        <population>63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit), 58 participants attended the 12 week FU (12 Subjects dropped)</population>
        <group_list>
          <group group_id="O1">
            <title>Treated Abdomen</title>
            <description>Subjects treated on the abdomen with SlimShape RF treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Abdominal Circumference After Treatments Compared to Baseline</title>
          <description>Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline</description>
          <population>63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit), 58 participants attended the 12 week FU (12 Subjects dropped)</population>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdominal circumference change at 4 week FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal circumference change at 8 week FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal circumference change at 12 week FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Treatments Where Participants Reported Having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; Response</title>
        <description>Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; )</description>
        <time_frame>First, second and third treatments, Weeks 0 to 4</time_frame>
        <population>70 participants attended the first treatment, 67 participants attended the second treatment (2 dropped and 1 missed treatment) and 65 participants attended the third treatment (3 dropped and 2 missed treatment), therefore overall 202 treatments conducted during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Treated Abdomen</title>
            <description>Subjects treated on the abdomen with SlimShape RF treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatments Where Participants Reported Having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; Response</title>
          <description>Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having &quot;Mild&quot;, &quot;Moderate&quot; or &quot;Severe&quot; )</description>
          <population>70 participants attended the first treatment, 67 participants attended the second treatment (2 dropped and 1 missed treatment) and 65 participants attended the third treatment (3 dropped and 2 missed treatment), therefore overall 202 treatments conducted during the study.</population>
          <units>Overall Treatments</units>
          <param>Count of Units</param>
          <units_analyzed>Overall Treatments</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Overall Treatments</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>The rate of erythema after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The rate of edema after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The rate of hematoma / purpura after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The rate of petechiae after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The rate of pain after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treated Abdomen</title>
          <description>Subjects treated on the abdomen with SlimShape RF treatments</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="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="10" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blisters</sub_title>
                <description>All blisters recovered during study period</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Vesicles</sub_title>
                <description>Vesicles on the left and right side of the abdomen</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Discoloration</sub_title>
                <description>Mild discoloration</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>firm mass</sub_title>
                <description>small 1x1 cm firm mass</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </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>Director of Clinical Affairs</name_or_title>
      <organization>Syneron Medical</organization>
      <phone>+972-73-2442347</phone>
      <email>shlomitm@syneron-candela.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/NCT02999763
org study id: DHF22621
nct id: NCT02999763
lead sponsor: 
has dmc: No
Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape
      device for non-invasive abdominal fat and circumference reduction.

      Study subjects will undergo SlimShape treatments on the abdominal area.
The objective of this trial is to evaluate the safety and efficacy of the SlimShape device
      utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference
      reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval)
      with the SlimShape device utilizing the SlimShape Applicator Belt according to the study
      protocol.

      The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and
      12 weeks (12wk FU) after the last treatment.

      Each subject will be enrolled for total expected study duration of up to 16 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Fat Thickness at Final Follow-up Compared to Baseline
time frame: Baseline and 12 weeks follow-up
description: Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline
measure: Change in Fat Thickness After Treatments Compared to Baseline
time frame: Baseline and 4 and 8 weeks follow-up
description: Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline
measure: Change in Abdominal Circumference After Treatments Compared to Baseline
time frame: At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)
description: Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline
measure: Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response
time frame: First, second and third treatments, Weeks 0 to 4
description: Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having "Mild", "Moderate" or "Severe" )
arm group label: Abdominal fat reduction treatment
arm group type: Experimental
description: SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants.
intervention type: Device
intervention name: SlimShape
description: SlimShape radiofrequency treatment to the abdomen
arm group label: Abdominal fat reduction treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ruthie Amir, MD
role: Study Director
affiliation: Syneron Medical
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Adatto MA, Adatto-Neilson RM, Morren G. Reduction in adipose tissue volume using a new high-power radiofrequency technology combined with infrared light and mechanical manipulation for body contouring. Lasers Med Sci. 2014 Sep;29(5):1627-31. doi: 10.1007/s10103-014-1564-x. Epub 2014 Apr 1.
PMID: 24687404
responsible party type: Sponsor
mesh term: Lipid Metabolism Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 