The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Treatment with BTL-703 device
Aesthe Clinic
Sofia, Bulgaria
RECRUITINGWaist circumference reduction
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
Time frame: 5 months
Serious adverse events following the treatment
Occurrence of serious adverse events will be followed throughout the whole study.
Time frame: 5 months
Photo evaluation
Correct identification of the pre- and post-treatment photos by blinded evaluators.
Time frame: 5 months
Subject Satisfaction
Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
Time frame: 5 months
Therapy discomfort
Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.
Time frame: 2 months
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