This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen. 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
70
Treatment with study device.
Ambulatory for Individual Practice for Specialized Outpatient Medical Care in Dermatology and Venereology Dr. Ivelina Yordanova-Vasileva
Pleven, Bulgaria
Dr. Lekova Derm Ltd.
Sofia, Bulgaria
Statistically significant reduction of abdominal fat thickness determined with ultrasound
To gather clinical evidence that BTL-785F system equipped with BTL-785-1 applicator is able to provide statistically significant reduction of at least 1,5 cm at the 3-months follow-up compared to baseline with a minimum response rate of 65% in both abdominal circumference and fat thickness.
Time frame: 5 months
Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen
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-785F device. Safety measures will include documentation of adverse events (AE) during and after the procedures.
Time frame: 5 months
Assessment of the participants' satisfaction from the therapy measured via standard questionnaire
Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy;
Time frame: 5 months
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