<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/NCT04419454</url>
  </required_header>
  <id_info>
    <org_study_id>DO609568A</org_study_id>
    <nct_id>NCT04419454</nct_id>
  </id_info>
  <brief_title>Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite</brief_title>
  <official_title>Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite</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>
      Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this preliminary report is to retrospectively evaluate this novel treatment&#xD;
      approach to improve the appearance of cellulite on the thighs and buttocks by tightening the&#xD;
      SFS using RFAL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Actual">July 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Photonumeric Cellulite Severity Score</measure>
    <time_frame>[ Time Frame: Baseline to 6 months posttreatment]</time_frame>
    <description>Change in Photonumeric Cellulite Severity Score 3. Investigator assessment of the cellulite improvement comparing pre and post treatment using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%) at all follow up visits.</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Cellulite</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BodyTite</intervention_name>
    <description>retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sample size will be a result of available charts from a 16-month retrospective review&#xD;
        January 2018 - May 2019. The sample will not include any vulnerable populations (pregnant&#xD;
        women, minors, or prisoners)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18years of age at the time of procedure&#xD;
&#xD;
               -  patients with localized lipodystrophy in the medial or lateral thigh, and visible&#xD;
                  cellulite of laxity in the lower extremity or buttocks&#xD;
&#xD;
               -  BodyTite treatments performed from January 2018 - May 2019 for Cellulite&#xD;
                  indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active infection, collagen disorders, immunocompromised state, medications that&#xD;
             mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o&#xD;
             BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and&#xD;
             cellulite of laxity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Petrs, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Mark Peters</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04419454
org study id: DO609568A
nct id: NCT04419454
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
The purpose of this preliminary report is to retrospectively evaluate this novel treatment
      approach to improve the appearance of cellulite on the thighs and buttocks by tightening the
      SFS using RFAL.
observational model: Cohort
time perspective: Retrospective
measure: Photonumeric Cellulite Severity Score
time frame: [ Time Frame: Baseline to 6 months posttreatment]
description: Change in Photonumeric Cellulite Severity Score 3. Investigator assessment of the cellulite improvement comparing pre and post treatment using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%) at all follow up visits.
intervention type: Device
intervention name: BodyTite
description: retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Petrs, MD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cellulite