HIFEM for Arms, Lower Limbs, and Oblique Muscles

Study Overview
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Brief Summary
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Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

Detailed Description
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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.

Official Title
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Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles

Conditions
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Muscle Tone Increased

Intervention / Treatment
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* Device: BTL 799-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed informed consent form BMI ≤ 30 kg/m2 Women of child-bearing potential are required to use birth control measures during the whole duration of the study Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation Exclusion Criteria: Cardiac pacemakers Implanted defibrillators, implanted neurostimulators Electronic implants Pulmonary insufficiency Metal implants Drug pumps Application in the head area Application in the heart area Malignant tumor Injured or otherwise impaired muscles Fever Pregnancy Sensitivity or allergy to latex Breastfeeding Following recent surgical procedures when muscle contraction may disrupt the healing process Application over areas of the skin which lack normal sensation Scars, open lesions and wounds at the treatment area Unrepaired abdominal hernia Patients after Cesarean section delivery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biceps circumference reduction<br>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii. | Device: BTL 799-2<br>* High power magnet system<br>|
| Experimental: Triceps circumference reduction<br>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii. | Device: BTL 799-2<br>* High power magnet system<br>|
| Experimental: Lower limb circumference reduction<br>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs. | Device: BTL 799-2<br>* High power magnet system<br>|
| Experimental: Oblique muscles toning<br>This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles. | Device: BTL 799-2<br>* High power magnet system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in adipose and muscle tissue measured via ultrasound imaging | 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction measured via questionnaires | 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. | 7 months | 
| Incidence Of Treatment-Related Adverse Events | 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 | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle strengthening, muscle tone