<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/NCT04506502</url>
  </required_header>
  <id_info>
    <org_study_id>ZA19-003</org_study_id>
    <nct_id>NCT04506502</nct_id>
  </id_info>
  <brief_title>Functional Change With MMS</brief_title>
  <acronym>FMS</acronym>
  <official_title>Functional Changes With Magnetic Muscle Stimulation of Abdominal Muscle</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 magnetic muscle stimulation (MMS) of abdominal muscle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">May 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>Body Satisfaction Scale (BSS)</measure>
    <time_frame>4-wk follow up visit</time_frame>
    <description>Change in subject perception of body shape using the Body Satisfaction Scale (BSS) at the 4-Week follow-up visit.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Muscle Toning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The ZELTIQ System</intervention_name>
    <description>The MMS device will be used to perform the treatments.</description>
    <arm_group_label>Muscle Toning</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 not had weight change exceeding 5% of body weight in the preceding month.&#xD;
&#xD;
          -  Subject agrees to maintain body weight within 5% during the study by not making any&#xD;
             changes in diet or exercise routine during the course of 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;
          -  Subject agrees to refrain from any new abdominal muscle training exercises of the&#xD;
             treatment area during the course of the study.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subject has had a recent surgical procedure(s) in the area of intended treatment and&#xD;
             muscle contractions may disrupt the healing process.&#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 had an intrauterine contraceptive device inserted or removed within the&#xD;
             past month.&#xD;
&#xD;
          -  Subject has a bleeding disorder or hemorrhagic condition&#xD;
&#xD;
          -  Subject is taking or has taken diet pills or supplements within the past month.&#xD;
&#xD;
          -  Subject has an active implanted electrical device such as a cardiac pacemaker,&#xD;
             cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery&#xD;
             system.&#xD;
&#xD;
          -  Subject has metal or electronic implants in or adjacent to the treatment area&#xD;
&#xD;
          -  Subject has an abdominal hernia.&#xD;
&#xD;
          -  Subject has pulmonary insufficiency.&#xD;
&#xD;
          -  Subject has a cardiac disorder.&#xD;
&#xD;
          -  Subject has a malignant tumor.&#xD;
&#xD;
          -  Subject has been diagnosed with a seizure disorder such as epilepsy.&#xD;
&#xD;
          -  Subject currently has a fever.&#xD;
&#xD;
          -  Subject is diagnosed with Grave's disease.&#xD;
&#xD;
          -  Subject has a growth plate in the treatment area&#xD;
&#xD;
          -  Subject is pregnant or intending to become pregnant during the study period (in the&#xD;
             next 9 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;
             device, investigational product or any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study.&#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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 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>Muscle Weakness</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/NCT04506502
org study id: ZA19-003
nct id: NCT04506502
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 magnetic muscle stimulation (MMS) of abdominal muscle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Body Satisfaction Scale (BSS)
time frame: 4-wk follow up visit
description: Change in subject perception of body shape using the Body Satisfaction Scale (BSS) at the 4-Week follow-up visit.
arm group label: Muscle Toning
arm group type: Experimental
description: The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.
intervention type: Device
intervention name: The ZELTIQ System
description: The MMS device will be used to perform the treatments.
arm group label: Muscle Toning
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: 
country: United States
responsible party type: Sponsor
mesh term: Muscle Weakness
sharing ipd: No