<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/NCT03304925</url>
  </required_header>
  <id_info>
    <org_study_id>ZA17-002</org_study_id>
    <nct_id>NCT03304925</nct_id>
  </id_info>
  <brief_title>CoolSculpting the Flanks</brief_title>
  <acronym>CSI</acronym>
  <official_title>CoolSculpting the Flanks</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 non-invasive subcutaneous fat layer reduction in the&#xD;
      flanks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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>Safety endpoint in relation to adverse events</measure>
    <time_frame>Final post treatment visit</time_frame>
    <description>Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness endpoint gauged by reduction in fat layer thickness</measure>
    <time_frame>Final post-treatment visit</time_frame>
    <description>Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject survey</measure>
    <time_frame>Final post-treatment visit</time_frame>
    <description>Subject survey as assessed by questionnaire administered at the final post-treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photo review</measure>
    <time_frame>Final post-treatment visit</time_frame>
    <description>Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">320</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 flanks 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;
          -  Male or female subjects &gt; 22 years of age and &lt; 65 years of age.&#xD;
&#xD;
          -  Subject has clearly visible fat on the flanks, which in the investigator's opinion,&#xD;
             may benefit from the treatment.&#xD;
&#xD;
          -  No weight change exceeding 5% of body weight in the preceding month.&#xD;
&#xD;
          -  Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds&#xD;
             multiplied by 703 divided by the square of the height in inches.&#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 course of the study.&#xD;
&#xD;
          -  Subject has read and signed the study written informed consent form.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subject has had a surgical procedure(s) 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&#xD;
             the area of intended treatment (e.g., heparin, insulin) within the past month.&#xD;
&#xD;
          -  Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold&#xD;
             hemoglobinuria.&#xD;
&#xD;
          -  Subject has a known history of Raynaud's disease, or any known condition with a&#xD;
             response to cold exposure that 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 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 has a history of hernia in the areas to be treated.&#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 other unapproved&#xD;
             investigational 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>Innovation Research Center</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinCare Physicians of Chestnut Hill</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zel Skin &amp; Laser Specialist</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brian S. Biesman, MD</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EpiCenter Skincare and Laser Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>95231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 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/NCT03304925
org study id: ZA17-002
nct id: NCT03304925
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 non-invasive subcutaneous fat layer reduction in the
      flanks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Safety endpoint in relation to adverse events
time frame: Final post treatment visit
description: Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
measure: Effectiveness endpoint gauged by reduction in fat layer thickness
time frame: Final post-treatment visit
description: Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
measure: Subject survey
time frame: Final post-treatment visit
description: Subject survey as assessed by questionnaire administered at the final post-treatment visit.
measure: Photo review
time frame: Final post-treatment visit
description: Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
arm group label: Fat Reduction
arm group type: Experimental
description: The treatments are designed to see if the fat can be reduced in the flanks 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: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipid Metabolism Disorders
sharing ipd: No