<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/NCT03815747</url>
  </required_header>
  <id_info>
    <org_study_id>BTL-799-MRI</org_study_id>
    <nct_id>NCT03815747</nct_id>
  </id_info>
  <brief_title>MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device</brief_title>
  <official_title>MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BTL Industries Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BTL Industries Ltd.</source>
  <oversight_info>
    <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>
      This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle&#xD;
      following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">January 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the device for toning of buttocks according to MRI images</measure>
    <time_frame>7 months</time_frame>
    <description>Evaluation of change in MRI images before and after the therapy procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject's satisfaction with study treatment</measure>
    <time_frame>7 months</time_frame>
    <description>Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects and adverse events (AE) associated with the study device</measure>
    <time_frame>7 months</time_frame>
    <description>The occurrence of side effects and adverse events will be followed throughout the whole study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Muscle Tone Increased</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-Intensity Focused Electromagnetic (HIFEM) Field Device</intervention_name>
    <description>The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 21 years&#xD;
&#xD;
          -  Voluntarily signed informed consent form&#xD;
&#xD;
          -  BMI ≤ 30 kg/m2&#xD;
&#xD;
          -  Women of child-bearing potential are required to use birth control measures during the&#xD;
             whole duration of the study&#xD;
&#xD;
          -  Subjects willing and able to abstain from partaking in any treatments other than the&#xD;
             study procedure to promote body contouring during study participation&#xD;
&#xD;
          -  Subjects willing and able to maintain his/her regular (pre-procedure) diet and&#xD;
             exercise regimen without effecting significant change in either direction during study&#xD;
             participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac pacemakers&#xD;
&#xD;
          -  Implanted defibrillators, implanted neurostimulators&#xD;
&#xD;
          -  Electronic implants&#xD;
&#xD;
          -  Pulmonary insufficiency&#xD;
&#xD;
          -  Metal implants&#xD;
&#xD;
          -  Drug pumps&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Following recent surgical procedures when muscle contraction may disrupt the healing&#xD;
             process&#xD;
&#xD;
          -  Application over areas of the skin which lack normal sensation&#xD;
&#xD;
          -  Scars, open lesions and wounds at the treatment area&#xD;
&#xD;
          -  Unrepaired abdominal hernia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Art of Skin MD</name>
      <address>
        <city>Solana Beach</city>
        <state>California</state>
        <zip>92075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 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 Hypertonia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 10, 2020</submitted>
    <returned>October 1, 2020</returned>
    <submitted>October 13, 2020</submitted>
    <returned>November 3, 2020</returned>
    <submitted>January 28, 2021</submitted>
    <returned>February 15, 2021</returned>
  </pending_results>
  <!-- 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/NCT03815747
org study id: BTL-799-MRI
nct id: NCT03815747
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle
      following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of the device for toning of buttocks according to MRI images
time frame: 7 months
description: Evaluation of change in MRI images before and after the therapy procedure.
measure: Subject's satisfaction with study treatment
time frame: 7 months
description: Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results.
measure: Side effects and adverse events (AE) associated with the study device
time frame: 7 months
description: The occurrence of side effects and adverse events will be followed throughout the whole study
arm group label: Treatment Group
arm group type: Experimental
description: Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device
intervention type: Device
intervention name: High-Intensity Focused Electromagnetic (HIFEM) Field Device
description: The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Muscle Hypertonia
submitted: September 10, 2020
returned: October 1, 2020
submitted: October 13, 2020
returned: November 3, 2020
submitted: January 28, 2021
returned: February 15, 2021