<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/NCT01671839</url>
  </required_header>
  <id_info>
    <org_study_id>CP-01-1004</org_study_id>
    <nct_id>NCT01671839</nct_id>
  </id_info>
  <brief_title>Study of the Cabochon System for Improvement in the Appearance of Cellulite</brief_title>
  <official_title>Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merz North America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ulthera, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merz North America, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System&#xD;
      for the improvement in the appearance of cellulite.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Mean Change (Decrease) in Cellulite Severity</measure>
    <time_frame>Treatment to 3 and 5 years</time_frame>
    <description>Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Cellulite Severity Grade</measure>
    <time_frame>3 and 5 years</time_frame>
    <description>Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved Appearance</measure>
    <time_frame>Treatment to 3 and 5 years</time_frame>
    <description>Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:&#xD;
Very much improved: Optimal cosmetic result in the treated areas for this subject&#xD;
Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition&#xD;
Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude&#xD;
No Change: The appearance of the treated areas is essentially the same as the original condition&#xD;
Worse: The appearance of the treated areas is worse than the original condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>Treatment to 3 and 5 years</time_frame>
    <description>Subject rated satisfaction according to a 5 point Likert scale after treatment:&#xD;
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Tolerability</measure>
    <time_frame>Treatment to 3 and 5 years</time_frame>
    <description>Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safe Treatment</measure>
    <time_frame>Treatment to 3 and 5 years</time_frame>
    <description>Freedom from serious adverse events directly attributable to the Cabochon System or procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Gynoid Lipodystrophy</condition>
  <arm_group>
    <arm_group_label>Subcutaneous tissue release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Subcutaneous tissue release with the Cabochon System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Subcutaneous tissue release with the Cabochon System</intervention_name>
    <description>Device: Subcutaneous tissue release</description>
    <arm_group_label>Subcutaneous tissue release</arm_group_label>
    <other_name>Cellfina®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, age 18-55&#xD;
&#xD;
          -  moderate or severe cellulite&#xD;
&#xD;
          -  BMI less than 35&#xD;
&#xD;
          -  will not to try any other cellulite treatments through 12M follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cellulite treatment on the thighs or buttocks in the last 90 days&#xD;
&#xD;
          -  prior liposuction in the thighs or buttocks&#xD;
&#xD;
          -  Greater than 10% increase or decrease in body weight within past 6 months&#xD;
&#xD;
          -  evidence of active infection or a fever &gt;38C&#xD;
&#xD;
          -  current or recent smoker&#xD;
&#xD;
          -  history of hypertension, diabetes or hypoglycemia&#xD;
&#xD;
          -  history of coagulopathy(ies) and/or on anticoagulant medication&#xD;
&#xD;
          -  history of cardiopathy or pneumopathy&#xD;
&#xD;
          -  history of severe anemia&#xD;
&#xD;
          -  has atrophic scars, or has a history of atrophic scars or keloids&#xD;
&#xD;
          -  taken within 14 days of treatment:&#xD;
&#xD;
               -  NSAIDs (e.g. aspirin, ibuprofen, naproxen)&#xD;
&#xD;
               -  Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark)&#xD;
&#xD;
               -  Herbal Teas&#xD;
&#xD;
          -  Subject is pregnant or lactating&#xD;
&#xD;
        For Extended Follow-Up the following apply:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the&#xD;
             Cabochon System for Improvement in the Appearance of Cellulite&#xD;
&#xD;
          -  Subject understands and accepts the obligation not to try or receive any other&#xD;
             cellulite treatments through 3 year follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has undergone an injected drug, energy-based device, minimally-invasive or&#xD;
             invasive procedure for contouring or cellulite on the buttocks or thighs since their&#xD;
             12 month study follow-up visit.&#xD;
&#xD;
          -  Subject has used skin care products (e.g. creams) for improvement in cellulite within&#xD;
             1 month prior to the follow-up visit.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Kaminer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin Care Physicians</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Coleman Center for Cosmetic and Dermatologic Surgery</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Laser Skin &amp; Vein Institute</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinCare Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <results_first_submitted>July 25, 2014</results_first_submitted>
  <results_first_submitted_qc>August 18, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 4, 2014</results_first_posted>
  <last_update_submitted>November 22, 2019</last_update_submitted>
  <last_update_submitted_qc>November 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</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>Lipodystrophy</mesh_term>
    <mesh_term>Cellulite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Subcutaneous Tissue Release</title>
          <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3-year Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>5-year Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Subcutaneous Tissue Release</title>
          <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </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="40.7" spread="9.1"/>
                  </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="55"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change (Decrease) in Cellulite Severity</title>
        <description>Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.</description>
        <time_frame>Treatment to 3 and 5 years</time_frame>
        <population>The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change (Decrease) in Cellulite Severity</title>
          <description>Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.</description>
          <population>The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.7" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.4" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Cellulite Severity Grade</title>
        <description>Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.</description>
        <time_frame>3 and 5 years</time_frame>
        <population>The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Cellulite Severity Grade</title>
          <description>Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.</description>
          <population>The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1" lower_limit="79.3" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="75" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improved Appearance</title>
        <description>Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:&#xD;
Very much improved: Optimal cosmetic result in the treated areas for this subject&#xD;
Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition&#xD;
Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude&#xD;
No Change: The appearance of the treated areas is essentially the same as the original condition&#xD;
Worse: The appearance of the treated areas is worse than the original condition</description>
        <time_frame>Treatment to 3 and 5 years</time_frame>
        <population>The primary analysis was based upon the complete case population (CC).</population>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release - 3 Years</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous Tissue Release - 5 Years</title>
          </group>
        </group_list>
        <measure>
          <title>Improved Appearance</title>
          <description>Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:&#xD;
Very much improved: Optimal cosmetic result in the treated areas for this subject&#xD;
Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition&#xD;
Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude&#xD;
No Change: The appearance of the treated areas is essentially the same as the original condition&#xD;
Worse: The appearance of the treated areas is worse than the original condition</description>
          <population>The primary analysis was based upon the complete case population (CC).</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="2.5" upper_limit="21.2"/>
                    <measurement group_id="O2" value="5.4" lower_limit="0.7" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="31.7" upper_limit="62.1"/>
                    <measurement group_id="O2" value="29.7" lower_limit="15.9" upper_limit="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" lower_limit="29.6" upper_limit="60"/>
                    <measurement group_id="O2" value="64.9" lower_limit="47.5" upper_limit="79.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6.9"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6.9"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction</title>
        <description>Subject rated satisfaction according to a 5 point Likert scale after treatment:&#xD;
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied</description>
        <time_frame>Treatment to 3 and 5 years</time_frame>
        <population>The primary analysis was based upon the complete case population (CC).</population>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release - 3 Years</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous Tissue Release - 5 Years</title>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subject rated satisfaction according to a 5 point Likert scale after treatment:&#xD;
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied</description>
          <population>The primary analysis was based upon the complete case population (CC).</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% Very Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2" lower_limit="27.7" upper_limit="57.9"/>
                    <measurement group_id="O2" value="46.0" lower_limit="29.5" upper_limit="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" lower_limit="35.8" upper_limit="66.3"/>
                    <measurement group_id="O2" value="32.4" lower_limit="18.0" upper_limit="49.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="1.4" upper_limit="18.3"/>
                    <measurement group_id="O2" value="18.9" lower_limit="8.0" upper_limit="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% Unsatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% Very Unsatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Tolerability</title>
        <description>Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score</description>
        <time_frame>Treatment to 3 and 5 years</time_frame>
        <population>The primary analysis was based upon the complete case population (CC).</population>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release - 3 Years</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous Tissue Release - 5 Years</title>
          </group>
        </group_list>
        <measure>
          <title>Procedure Tolerability</title>
          <description>Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score</description>
          <population>The primary analysis was based upon the complete case population (CC).</population>
          <units>units on 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="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safe Treatment</title>
        <description>Freedom from serious adverse events directly attributable to the Cabochon System or procedure.</description>
        <time_frame>Treatment to 3 and 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subcutaneous Tissue Release - 3 Years</title>
            <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous Tissue Release - 5 Years</title>
          </group>
        </group_list>
        <measure>
          <title>Safe Treatment</title>
          <description>Freedom from serious adverse events directly attributable to the Cabochon System or procedure.</description>
          <units>occurence of serious adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to year 5.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Subcutaneous Tissue Release - 3 Years</title>
          <description>Device: Subcutaneous tissue release with the Cabochon System&#xD;
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release</description>
        </group>
        <group group_id="E2">
          <title>Subcutaneous Tissue Release - Years 4-5</title>
        </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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_at_risk="37"/>
              </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>Investigator agrees that the first publication of the results shall be made in conjunction with the results from all study centers. If Investigator desires independently to publish information about data obtained at Investigator's facility, then Investigator may do so, provided a copy of any proposed oral presentation or written publication is received by Company at least 45 days in advance of submission for publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Public Disclosure Manager</name_or_title>
      <organization>Merz Pharmaceuticals</organization>
      <phone>+49 69 1503 0</phone>
      <email>clinicaltrials@merz.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/NCT01671839
org study id: CP-01-1004
nct id: NCT01671839
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System
      for the improvement in the appearance of cellulite.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change (Decrease) in Cellulite Severity
time frame: Treatment to 3 and 5 years
description: Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.
measure: Improvement in Cellulite Severity Grade
time frame: 3 and 5 years
description: Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.
measure: Improved Appearance
time frame: Treatment to 3 and 5 years
description: Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:
Very much improved: Optimal cosmetic result in the treated areas for this subject
Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition
Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude
No Change: The appearance of the treated areas is essentially the same as the original condition
Worse: The appearance of the treated areas is worse than the original condition
measure: Subject Satisfaction
time frame: Treatment to 3 and 5 years
description: Subject rated satisfaction according to a 5 point Likert scale after treatment:
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
measure: Procedure Tolerability
time frame: Treatment to 3 and 5 years
description: Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score
measure: Safe Treatment
time frame: Treatment to 3 and 5 years
description: Freedom from serious adverse events directly attributable to the Cabochon System or procedure.
arm group label: Subcutaneous tissue release
arm group type: Experimental
description: Device: Subcutaneous tissue release with the Cabochon System
intervention type: Device
intervention name: Subcutaneous tissue release with the Cabochon System
description: Device: Subcutaneous tissue release
arm group label: Subcutaneous tissue release
other name: Cellfina®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S Kaminer
role: Principal Investigator
affiliation: Skin Care Physicians
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipodystrophy
mesh term: Cellulite
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 