High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
- Conditions
- Muscle Tone
- Interventions
- Device: BTL-899 Buttocks
- Registration Number
- NCT04871503
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIFEM+RF (HR) BTL-899 Buttocks 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. HIFEM (H) BTL-899 Buttocks 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.
- Primary Outcome Measures
Name Time Method The evaluation of change in adipose and muscle layer thickness. 4 months The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements.
The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups. 4 months 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
- Secondary Outcome Measures
Name Time Method Patient's satisfaction with study treatment measured via questionnaires 4 months 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.
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire 4 months 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.
Trial Locations
- Locations (5)
Refresh Dermatology
🇺🇸Houston, Texas, United States
Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
🇺🇸Hackensack, New Jersey, United States
JUVA Skin & Laser Center
🇺🇸New York, New York, United States
New Jersey Plastic Surgery (NJPS)
🇺🇸Montclair, New Jersey, United States
Contour Medical
🇺🇸Gilbert, Arizona, United States