The study is a prospective open-label single-arm 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 open-label single-arm study. The subjects will be enrolled and assigned into a single study group. 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
BTL-899
Aesthe Clinic
Sofia, Bulgaria
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
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 fat and circumference reduction in abdomen, as assessed by two blinded evaluators
Evaluation of photographs before and after the treatment.
Time frame: 4 months
Efficacy of the BTL-899 treatment for abdomen circumference reduction
Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.
Time frame: 4 months
Ultrasound imaging
Evaluation of 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).
Time frame: 1 month
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