High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks

Study Overview
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Brief Summary
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This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.

Official Title
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Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks

Conditions
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Muscle Tone

Intervention / Treatment
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* Device: BTL-899 Buttocks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 years Voluntarily signed an informed consent form BMI ≤ 35 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 affecting significant change in either direction during study participation Exclusion Criteria: Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) Metal implants Drug pumps Malignant tumor Pulmonary insufficiency Injured or otherwise impaired muscles Cardiovascular diseases Disturbance of temperature or pain perception Hemorrhagic conditions Septic conditions and empyema Acute inflammations Systemic or local infection such as osteomyelitis and tuberculosis Contagious skin disease Elevated body temperature Pregnancy, postpartum period, nursing, and menstruation Intrauterine device (IUD) Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area Basedow's disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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
Interventional Model Description: The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFEM+RF (HR)<br>The HR group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with mild heating of the muscles. | Device: BTL-899 Buttocks<br>* The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.<br>|
| Experimental: HIFEM (H)<br>The H group will receive a treatment with the intensities of the magnetic field just below the patient's tolerance threshold without the use of radiofrequency. | Device: BTL-899 Buttocks<br>* The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups. | The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues | 4 months | 
| The evaluation of change in adipose and muscle layer thickness. | The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction with study treatment measured via questionnaires | To determine the patient's satisfaction with study treatment. The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4therapy-related questions, where the answer Strongly agree will be the best possible answer and Strongly disagree the worst. | 4 months | 
| Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. The outcome will further be measured through the occurrence of adverse events or lack thereof. | 4 months |