<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/NCT03769649</url>
  </required_header>
  <id_info>
    <org_study_id>DO608110</org_study_id>
    <nct_id>NCT03769649</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of CelluTite Treatment</brief_title>
  <official_title>Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InMode MD Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InMode MD Ltd.</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>
      This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with&#xD;
      Morpheus8 handpiece for the treatment of cellulite.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:&#xD;
&#xD;
        -  The CelluTite - based on a minimally invasive, temperature-controlled&#xD;
           Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a&#xD;
           handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and&#xD;
           external electrode.&#xD;
&#xD;
        -  The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner&#xD;
           via an array of 24-electrode pins.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">January 17, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</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>Subjects will receive the treatment and outcome will be followed</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</measure>
    <time_frame>6 months</time_frame>
    <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</measure>
    <time_frame>6 months</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</measure>
    <time_frame>6 months</time_frame>
    <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</measure>
    <time_frame>1 month</time_frame>
    <description>Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</measure>
    <time_frame>3 months</time_frame>
    <description>Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</measure>
    <time_frame>1 month</time_frame>
    <description>Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</measure>
    <time_frame>3 months</time_frame>
    <description>Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</measure>
    <time_frame>1 week</time_frame>
    <description>Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</measure>
    <time_frame>1 week</time_frame>
    <description>Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Adverse Events Occurrence Based on Severity</measure>
    <time_frame>3 months</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Adverse Events Occurrence Based on Severity</measure>
    <time_frame>1 month</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Adverse Events Occurrence Based on Severity</measure>
    <time_frame>1 week</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Adverse Events Occurrence Based on Severity</measure>
    <time_frame>Treatment Day</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Adverse Events Occurrence Based on Severity</measure>
    <time_frame>6 Months</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</measure>
    <time_frame>3 months</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</measure>
    <time_frame>1 week</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</measure>
    <time_frame>Treatment Day</time_frame>
    <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cellulite of Thighs</condition>
  <arm_group>
    <arm_group_label>Treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CelluTite</intervention_name>
    <description>CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>Morpheus8</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects aged 18-70 having mild/moderate grade cellulites.&#xD;
&#xD;
          -  The patients should understand the information provided about the treatment, possible&#xD;
             benefits and side effects, and sign the Informed Consent Form, (including the&#xD;
             permission to use photography).&#xD;
&#xD;
          -  The patients should be willing to comply with the study procedure and schedule,&#xD;
             including the follow up visit, and will refrain from using any other aesthetic&#xD;
             treatment methods in the treatment area for the last 6 months and during the entire&#xD;
             study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body fat layer thinner than 5mm.&#xD;
&#xD;
          -  Pacemaker or internal defibrillator, or any other active electrical implant anywhere&#xD;
             in the body.&#xD;
&#xD;
          -  Superficial permanent implant in the treated area such as metal plates and screws,&#xD;
             metal piercing, silicone implants or an injected chemical substance.&#xD;
&#xD;
          -  Current or history of skin cancer (remission of 5 years), or current condition of any&#xD;
             other type of cancer, or pre-malignant moles.&#xD;
&#xD;
          -  Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled&#xD;
             hypertension, and liver or kidney diseases.&#xD;
&#xD;
          -  Pregnancy and nursing.&#xD;
&#xD;
          -  History of bleeding coagulopathies or use of anticoagulants.&#xD;
&#xD;
          -  Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use&#xD;
             of immunosuppressive medications.&#xD;
&#xD;
          -  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and&#xD;
             hormonal virilization.&#xD;
&#xD;
          -  Any active condition in the treatment area, such as sores, psoriasis, eczema, and&#xD;
             rash.&#xD;
&#xD;
          -  History of skin disorders, keloids, abnormal wound healing, as well as very dry and&#xD;
             fragile skin.&#xD;
&#xD;
          -  Use of Isotretinoin (Accutane®) within 6 months prior to treatment.&#xD;
&#xD;
          -  Any surgery or treatment such as laser or chemicals in treated area within 3-6 months&#xD;
             prior to treatment or before complete healing.&#xD;
&#xD;
          -  Allergies, in particular to anesthesia.&#xD;
&#xD;
          -  Mental disorders such as Body Dysmorphic Disorder (BDD).&#xD;
&#xD;
          -  As per the practitioner's discretion, refrain from treating any condition that might&#xD;
             make it unsafe for the patient.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Bruce Katz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>60 E 56th St #2, New York, NY 10022, USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juva</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>December 4, 2020</results_first_submitted>
  <results_first_submitted_qc>January 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2021</results_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2022</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>
  <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>August 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03769649/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Arm</title>
          <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only subjects that finished all visits were analyzed</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Arm</title>
          <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="50.62" spread="8.83"/>
                  </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="11"/>
                  </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>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White Non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
          <description>Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.45" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
          <description>Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.55" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
        <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
          <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
        <time_frame>6 months</time_frame>
        <population>Only subjects completed 6 month FU</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
          <population>Only subjects completed 6 month FU</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
        <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
          <description>Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.64" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
        <description>Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
          <description>Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).&#xD;
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
        <description>Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
          <description>Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
        <description>Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
          <description>Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
        <description>Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
          <description>Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.64" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
        <description>Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)</title>
          <description>Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
        <description>Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)</title>
          <description>Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Adverse Events Occurrence Based on Severity</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
        <time_frame>3 months</time_frame>
        <population>Only subjects completed 3 M FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Adverse Events Occurrence Based on Severity</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
          <population>Only subjects completed 3 M FU were analyzed</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Adverse Events Occurrence Based on Severity</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
        <time_frame>1 month</time_frame>
        <population>Only subjects completed 1 Month FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Adverse Events Occurrence Based on Severity</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
          <population>Only subjects completed 1 Month FU were analyzed</population>
          <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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Adverse Events Occurrence Based on Severity</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
        <time_frame>1 week</time_frame>
        <population>Only subjects completed 1 week FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Adverse Events Occurrence Based on Severity</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
          <population>Only subjects completed 1 week FU were analyzed</population>
          <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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Adverse Events Occurrence Based on Severity</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
        <time_frame>Treatment Day</time_frame>
        <population>All subjects undergone treatment were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Adverse Events Occurrence Based on Severity</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
          <population>All subjects undergone treatment were analyzed</population>
          <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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
        <time_frame>6 months</time_frame>
        <population>Only subjects completed 6 months FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
          <population>Only subjects completed 6 months FU were analyzed</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Adverse Events Occurrence Based on Severity</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
        <time_frame>6 Months</time_frame>
        <population>Only subjects completed 6 M FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Adverse Events Occurrence Based on Severity</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).</description>
          <population>Only subjects completed 6 M FU were analyzed</population>
          <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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
        <time_frame>3 months</time_frame>
        <population>Only subjects completed 6 months FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
          <population>Only subjects completed 6 months FU were analyzed</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
        <time_frame>1 week</time_frame>
        <population>Only subjects completed 1 week FU were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
          <population>Only subjects completed 1 week FU were analyzed</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
        <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
        <time_frame>Treatment Day</time_frame>
        <population>Only subjects completed treatment were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)</title>
          <description>Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.</description>
          <population>Only subjects completed treatment were analyzed</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over a period of 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Arm</title>
          <description>Subjects receive CelluTite treatment followed by Morpheus8 treatment&#xD;
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF</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="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </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="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <description>Anticipated event of pain post procedure in the treatment area that resolved after approximately a month.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </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>Maria Shusterman</name_or_title>
      <organization>InMode</organization>
      <phone>855.411.2639</phone>
      <email>marias@inmodemd.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/NCT03769649
org study id: DO608110
nct id: NCT03769649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with
      Morpheus8 handpiece for the treatment of cellulite.
The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:

        -  The CelluTite - based on a minimally invasive, temperature-controlled
           Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a
           handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and
           external electrode.

        -  The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner
           via an array of 24-electrode pins.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects will receive the treatment and outcome will be followed
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
time frame: 6 months
description: Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
time frame: 6 months
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
time frame: 6 months
description: Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
time frame: 1 month
description: Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
time frame: 3 months
description: Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
time frame: 1 month
description: Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
time frame: 3 months
description: Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
time frame: 1 week
description: Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
time frame: 1 week
description: Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
measure: Assessment of Adverse Events Occurrence Based on Severity
time frame: 3 months
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
measure: Assessment of Adverse Events Occurrence Based on Severity
time frame: 1 month
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
measure: Assessment of Adverse Events Occurrence Based on Severity
time frame: 1 week
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
measure: Assessment of Adverse Events Occurrence Based on Severity
time frame: Treatment Day
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
measure: Assessment of Adverse Events Occurrence Based on Severity
time frame: 6 Months
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
time frame: 3 months
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
time frame: 1 week
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
time frame: Treatment Day
description: Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
arm group label: Treatment arm
arm group type: Experimental
description: Subjects receive CelluTite treatment followed by Morpheus8 treatment
intervention type: Device
intervention name: CelluTite
description: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
arm group label: Treatment arm
other name: Morpheus8
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Katz, MD
role: Principal Investigator
affiliation: 60 E 56th St #2, New York, NY 10022, USA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cellulite
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 