<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/NCT04426526</url>
  </required_header>
  <id_info>
    <org_study_id>BTL-799_600</org_study_id>
    <nct_id>NCT04426526</nct_id>
  </id_info>
  <brief_title>HIFEM for Arms, Lower Limbs, and Oblique Muscles</brief_title>
  <official_title>Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles</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>
    <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>
      Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique&#xD;
      muscles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the clinical efficacy and safety of the high power magnet system for&#xD;
      toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective&#xD;
      multi-center open-label four-arm study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2019</start_date>
  <completion_date type="Actual">December 8, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in adipose and muscle tissue measured via ultrasound imaging</measure>
    <time_frame>7 months</time_frame>
    <description>To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction measured via questionnaires</measure>
    <time_frame>7 months</time_frame>
    <description>To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between &quot;strongly agree&quot; and &quot;strongly disagree&quot; should indicate the participant's satisfaction with the therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Of Treatment-Related Adverse Events</measure>
    <time_frame>7 months</time_frame>
    <description>To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following:&#xD;
Muscle pain&#xD;
Temporary muscle spasm&#xD;
Temporary joint or tendon pain&#xD;
Local erythema or skin redness</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Muscle Tone Increased</condition>
  <arm_group>
    <arm_group_label>Biceps circumference reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triceps circumference reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower limb circumference reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oblique muscles toning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BTL 799-2</intervention_name>
    <description>High power magnet system</description>
    <arm_group_label>Biceps circumference reduction</arm_group_label>
    <arm_group_label>Lower limb circumference reduction</arm_group_label>
    <arm_group_label>Oblique muscles toning</arm_group_label>
    <arm_group_label>Triceps circumference reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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;
          -  Injured or otherwise impaired muscles&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sensitivity or allergy to latex&#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>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>Plastic Surgical Associates</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juva Skin &amp; Laser Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>muscle strengthening</keyword>
  <keyword>muscle tone</keyword>
  <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/NCT04426526
org study id: BTL-799_600
nct id: NCT04426526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique
      muscles.
This study will evaluate the clinical efficacy and safety of the high power magnet system for
      toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective
      multi-center open-label four-arm study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in adipose and muscle tissue measured via ultrasound imaging
time frame: 7 months
description: To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.
measure: Patient's satisfaction measured via questionnaires
time frame: 7 months
description: To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between "strongly agree" and "strongly disagree" should indicate the participant's satisfaction with the therapy.
measure: Incidence Of Treatment-Related Adverse Events
time frame: 7 months
description: To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following:
Muscle pain
Temporary muscle spasm
Temporary joint or tendon pain
Local erythema or skin redness
arm group label: Biceps circumference reduction
arm group type: Experimental
description: This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii.
arm group label: Triceps circumference reduction
arm group type: Experimental
description: This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii.
arm group label: Lower limb circumference reduction
arm group type: Experimental
description: This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs.
arm group label: Oblique muscles toning
arm group type: Experimental
description: This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles.
intervention type: Device
intervention name: BTL 799-2
description: High power magnet system
arm group label: Biceps circumference reduction
arm group label: Lower limb circumference reduction
arm group label: Oblique muscles toning
arm group label: Triceps circumference reduction
criteria: 
gender: All
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