The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.
This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Treatment with study device.
Aesthe Clinic
Sofia, Bulgaria
Changes in Fat Thickness Measured via Ultrasound
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound.
Time frame: 6 months
Participants' Satisfaction Measured Via Questionnaires
Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse".
Time frame: 6 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
The outcome will further be measured through the occurrence of adverse events or lack thereof. 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.
Time frame: 6 months
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