This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. The changes in the fat tissue related to the morphology (shape, size and count) will be assessed histologically. The presence of biochemical apoptotic indicators will be analysed in the adipocytes. The study is a prospective single-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment (5 subjects) and Group B (2 subjects), will serve as the control, and will not receive any treatment to verify the treatment outcomes. Subjects will be required to complete one (1) treatment visit and three (3) follow-up visits (at 24 hours, 7 days and 14 days post treatment). The third follow-up visit is for safety evaluation. At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. Punch biopsies (3mm diameter) will be obtained from the treatment area for histologic analysis. In the control group, biopsy will be obtained from the location corresponding to the treatment area in the active group. Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow up visits and if needed medical assistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area
Schweiger Dermatology PC, Research Division
Hackensack, New Jersey, United States
Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells.
Histological evaluation of changes in the shape and size of submental adipose cells, based on biopsies obtained from both the treatment and control groups.
Time frame: 6 months
Investigation of post-treatment adipocyte apoptosis
Histologically analyze the adipocyte tissue for the change in apoptosis markers (caspase-3/7 and Bcl-2) levels.
Time frame: 6 months
Incidence of Treatment-related Adverse Events
Evaluation of the safety of the BTL-785F device with BTL-785-7 applicator for non-invasive treatment of the submental area throught monitoring of adverse events
Time frame: 6 months
Comfort Evaluation Assessed by Therapy Comfort Questionnaire
Evaluation of therapy comfort using the 5-point Likert scale Therapy Comfort Questionnaire given to subjects after the treatment, where the best possible answer would be "strongly agree" and the worst "strongly disagree". The questionnaire includes pain sensation rating on the scale from 0 (no pain) to 10 (worst possible pain), where 0 (no pain) represents the best possible outcome.
Time frame: 6 months
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