Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.
Shah Aesthetic Surgery
Denver, Colorado, United States
Medical Management Solutions INC
Foxborough, Massachusetts, United States
SRS Dermatology
Woodmere, New York, United States
Patient Overall Satisfaction
Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions
Time frame: Week 26
Patient Treatment Satisfaction
Patients rate their treatment satisfaction using a 5 point Likert Scale. The Likert scale ranges from 1 = very unsatisfied 2 = unsatisfied 3 = neutral 4 = satisfied 5 = very satisfied
Time frame: Week 26
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