<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/NCT03758690</url>
  </required_header>
  <id_info>
    <org_study_id>BTL-After Childbirth</org_study_id>
    <nct_id>NCT03758690</nct_id>
  </id_info>
  <brief_title>High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth</brief_title>
  <official_title>Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth</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>
      Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women&#xD;
      after childbirth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2018</start_date>
  <completion_date type="Actual">January 2, 2020</completion_date>
  <primary_completion_date type="Actual">August 13, 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 abdominal toning according to MRI images</measure>
    <time_frame>7 months</time_frame>
    <description>Evaluation of MRI images before and after the therapy procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of the device for abdominal toning according to waist circumference measurements</measure>
    <time_frame>7 months</time_frame>
    <description>Evaluation of waist circumference measurements (in centimeters).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject's satisfaction with study treatment: Questionnaire</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>Determination of 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">10</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;
          -  Non-breastfeeding women 3-36 months after childbirth&#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 her regular (pre-procedure) diet and exercise&#xD;
             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;
          -  Application in the head area&#xD;
&#xD;
          -  Application in the heart area&#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;
&#xD;
          -  Patients after Cesarean section delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Skin Care Physicians of Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Cosmetic Surgery and Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</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>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 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>
  <!-- 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/NCT03758690
org study id: BTL-After Childbirth
nct id: NCT03758690
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women
      after childbirth.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of the device for abdominal toning according to MRI images
time frame: 7 months
description: Evaluation of MRI images before and after the therapy procedure.
measure: Effectiveness of the device for abdominal toning according to waist circumference measurements
time frame: 7 months
description: Evaluation of waist circumference measurements (in centimeters).
measure: Subject's satisfaction with study treatment: Questionnaire
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: Determination of 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: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Muscle Hypertonia