<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/NCT04506307</url>
  </required_header>
  <id_info>
    <org_study_id>ZA20-001</org_study_id>
    <nct_id>NCT04506307</nct_id>
  </id_info>
  <brief_title>CoolSculpting System</brief_title>
  <acronym>ELI</acronym>
  <official_title>Noninvasive Fat Reduction With the CoolSculpting System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeltiq Aesthetics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeltiq Aesthetics</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>
      Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the&#xD;
      purpose of non-invasive fat reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy Endpoint: Independent Photo Review</measure>
    <time_frame>one-month post final data collection</time_frame>
    <description>Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the pre-treatment images.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint: AE's</measure>
    <time_frame>one-month post final data collection</time_frame>
    <description>The frequency of device and procedure-related adverse events (AEs), including device-related serious adverse events (SADEs), will be summarized.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Body Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Fat Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatments are designed to see if the fat can be reduced in the torso area with a new applicator design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The ZELTIQ System</intervention_name>
    <description>The CoolSculpting machine will be used to perform the treatments.</description>
    <arm_group_label>Fat Reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subject (healthy volunteer) has read and signed the study written informed consent&#xD;
             form.&#xD;
&#xD;
          -  Male or female ≥ 22 years and ≤65 years of age.&#xD;
&#xD;
          -  Subject has clearly visible fat in one or more areas on the torso (abdomen, flank,&#xD;
             back fat, bra fat), which in the investigator's opinion, may benefit from the&#xD;
             treatment.&#xD;
&#xD;
          -  Subject has not had weight change exceeding 5% of body weight in the preceding month.&#xD;
&#xD;
          -  Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major&#xD;
             changes in their diet or exercise routine during the study.&#xD;
&#xD;
          -  Subject has a BMI ≤ 30 as determined at screening.&#xD;
&#xD;
          -  Subject agrees to have photographs taken of the treatment area(s) during the scheduled&#xD;
             time periods.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subject has had a recent surgical procedure in the area of intended treatment.&#xD;
&#xD;
          -  Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy)&#xD;
             in the area of intended treatment.&#xD;
&#xD;
          -  Subject has had a non-invasive fat reduction and/or body contouring procedure in the&#xD;
             area of intended treatment within the past 12 months.&#xD;
&#xD;
          -  Subject needs to administer or has a known history of subcutaneous injections into the&#xD;
             area of intended treatment (e.g., heparin, insulin) within the past month.&#xD;
&#xD;
          -  Subject has a known history of cryoglobulinemia, paroxysmal cold hemoglobinuria, or&#xD;
             cold agglutinin disease.&#xD;
&#xD;
          -  Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease,&#xD;
             chilblains (pernio), or any known condition with a response to cold exposure that&#xD;
             limits blood flow to the skin.&#xD;
&#xD;
          -  Subject has a history of bleeding disorder or is taking any medication that in the&#xD;
             investigator's opinion may increase the subject's risk of bruising.&#xD;
&#xD;
          -  Subject is taking or has taken diet pills or supplements within the past month.&#xD;
&#xD;
          -  Subject has any dermatological conditions, such as moderate to excessive skin laxity,&#xD;
             or scars in the location of the treatment sites that may interfere with the treatment&#xD;
             or evaluation (stretch marks is not an exclusion).&#xD;
&#xD;
          -  Subject has an active implanted device such as a pacemaker, defibrillator, or drug&#xD;
             delivery system&#xD;
&#xD;
          -  Subject has a history of hernia in the area(s) to be treated.&#xD;
&#xD;
          -  Subject is pregnant or intending to become pregnant during the study period (in the&#xD;
             next 8 months).&#xD;
&#xD;
          -  Subject is lactating or has been lactating in the past 6 months.&#xD;
&#xD;
          -  Subject is unable or unwilling to comply with the study requirements.&#xD;
&#xD;
          -  Subject is currently enrolled in a clinical study of any unapproved investigational&#xD;
             drug or device.&#xD;
&#xD;
          -  Any other condition or laboratory value that would, in the professional opinion of the&#xD;
             investigator, potentially affect the subject's response or the integrity of the data&#xD;
             or would pose an unacceptable risk to the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerrie Jiang, NP</last_name>
    <role>Study Director</role>
    <affiliation>Zeltiq Aesthetics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marina Plastic Surgery</name>
      <address>
        <city>Marina Del Rey</city>
        <state>California</state>
        <zip>90292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverchase Dermatology</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</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>Lipid Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04506307
org study id: ZA20-001
nct id: NCT04506307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the
      purpose of non-invasive fat reduction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Efficacy Endpoint: Independent Photo Review
time frame: one-month post final data collection
description: Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the pre-treatment images.
measure: Safety Endpoint: AE's
time frame: one-month post final data collection
description: The frequency of device and procedure-related adverse events (AEs), including device-related serious adverse events (SADEs), will be summarized.
arm group label: Fat Reduction
arm group type: Experimental
description: The treatments are designed to see if the fat can be reduced in the torso area with a new applicator design.
intervention type: Device
intervention name: The ZELTIQ System
description: The CoolSculpting machine will be used to perform the treatments.
arm group label: Fat Reduction
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kerrie Jiang, NP
role: Study Director
affiliation: Zeltiq Aesthetics
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipid Metabolism Disorders
sharing ipd: No