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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
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.
Contour Medical
Gilbert, Arizona, United States
Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
Hackensack, New Jersey, United States
New Jersey Plastic Surgery (NJPS)
Montclair, New Jersey, United States
JUVA Skin & Laser Center
New York, New York, United States
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
Time frame: 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.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 4 months
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Refresh Dermatology
Houston, Texas, United States