The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Dr-Denkova Dermatology
Sofia, Bulgaria
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
Time frame: 4 months
Occurrence of adverse events
The occurrence of adverse events will be followed throughout the whole study.
Time frame: 7 months
Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators
Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.
Time frame: 4 months
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.
Time frame: 4 months
Efficacy of the BTL-899 treatment for abdominal fat reduction
Comparison of fat reduction between two study groups using ultrasound images.
Time frame: 4 months
Subject's satisfaction with study treatment
Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
Time frame: 4 months
Therapy comfort during the study treatment.
Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
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Time frame: 1 month