<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/NCT01728857</url>
  </required_header>
  <id_info>
    <org_study_id>ZA12-007</org_study_id>
    <nct_id>NCT01728857</nct_id>
  </id_info>
  <brief_title>Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction</brief_title>
  <acronym>TOPS</acronym>
  <official_title>The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the&#xD;
      outcome of non-invasive fat reduction using the ZELTIQ System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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</measure>
    <time_frame>16 weeks post final treatment</time_frame>
    <description>Effectiveness: Comparison of pre- and 16-week post-treatment photographs of the treatment areas to select the side with greater improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Photographs pre and 8-week post</measure>
    <time_frame>8 weeks post final treatment</time_frame>
    <description>Comparison of pre- and 8-week post-treatment photographs of the treatment areas to select the side with greater improvement.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Body Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Fat Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Zeltiq System</intervention_name>
    <description>Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.</description>
    <arm_group_label>Fat Reduction</arm_group_label>
    <other_name>Cryolipolysis</other_name>
    <other_name>Lipolysis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Male or female subjects &gt; 18 years of age and &lt; 65 years of age.&#xD;
&#xD;
          2. Subject has clearly visible fat on intended treatment area, which in the&#xD;
             investigator's opinion, may benefit from the treatment(s).&#xD;
&#xD;
          3. Subject has not had weight change exceeding 10 pounds in the preceding month.&#xD;
&#xD;
          4. Subject with body mass index (BMI) less than 30. BMI is defined as weight in pounds&#xD;
             multiplied by 703 divided by the square of the height in inches.&#xD;
&#xD;
          5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any&#xD;
             major changes in their diet or lifestyle during the course of the study.&#xD;
&#xD;
          6. Subject has read and signed a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subject presents a significant asymmetry of intended treatment areas.&#xD;
&#xD;
          2. Subject has had a surgical procedure(s) in the area of intended treatment in the past&#xD;
             5 years..&#xD;
&#xD;
          3. Subject has had an invasive fat reduction procedure (e.g., liposuction,&#xD;
             abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.&#xD;
&#xD;
          4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the&#xD;
             area of intended treatment within the past 6 months.&#xD;
&#xD;
          5. 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;
          6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold&#xD;
             hemoglobinuria.&#xD;
&#xD;
          7. 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;
          8. 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;
          9. Subject is taking or has taken diet pills or weight control supplements within the&#xD;
             past month.&#xD;
&#xD;
         10. 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;
         11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug&#xD;
             delivery system.&#xD;
&#xD;
         12. Subject is pregnant or intending to become pregnant in the next 5 months.&#xD;
&#xD;
         13. Subject is lactating or has been lactating in the past 6 months.&#xD;
&#xD;
         14. Subject has a history of hernia in the areas to be treated.&#xD;
&#xD;
         15. Subject is unable or unwilling to comply with the study requirements.&#xD;
&#xD;
         16. Subject is currently enrolled in a clinical study of any other unapproved&#xD;
             investigational drug or device.&#xD;
&#xD;
         17. 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>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Bachelor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Innovation Research Center</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>June 20, 2017</last_update_submitted>
  <last_update_submitted_qc>June 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lipolysis</keyword>
  <keyword>Cryolipolysis</keyword>
  <keyword>Fat Reduction</keyword>
  <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/NCT01728857
org study id: ZA12-007
nct id: NCT01728857
lead sponsor: 
has dmc: No
Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the
      outcome of non-invasive fat reduction using the ZELTIQ System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Efficacy
time frame: 16 weeks post final treatment
description: Effectiveness: Comparison of pre- and 16-week post-treatment photographs of the treatment areas to select the side with greater improvement.
measure: Photographs pre and 8-week post
time frame: 8 weeks post final treatment
description: Comparison of pre- and 8-week post-treatment photographs of the treatment areas to select the side with greater improvement.
arm group label: Fat Reduction
arm group type: Experimental
intervention type: Device
intervention name: The Zeltiq System
description: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
arm group label: Fat Reduction
other name: Cryolipolysis
other name: Lipolysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Bachelor, MD
role: Principal Investigator
affiliation: Innovation Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipid Metabolism Disorders
sharing ipd: No