This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound. At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device. Safety measures will include documentation of adverse events (AE) during and after the procedures. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Combination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field.
Outpatient Practice for Specialized Medical Care - Individual practice for specialized medical dermatology care Mariya Genova MD
Plovdiv, Bulgaria
Change of fat thickness in the flanks area evaluated by ultrasound
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on human flanks
Time frame: 5 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Assessment the safety of the BTL-899 device when used for non-invasive lipolysis of the flanks via questionnaires filled in by the participants following each therapy session. 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: 5 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
Majority of the treated subjects to report satisfaction (level satisfied and higher) with the therapy.
Time frame: 5 months
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