The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time. VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.
All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.
BC Laser & SkinCare Clinic
Surrey, British Columbia, Canada
Cosmedica
Pointe-Claire, Quebec, Canada
Difference in circumference reduction between baseline and follow-up visits
The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:
Time frame: Base line, 2 and 12 weeks post last treatment
Adverse Events
Safety will be evaluated based on the incidence and severity of adverse events caused by the treatments
Time frame: The duration of the study, an expected average of 5 months.
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