The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
36
Study of Adipose Tissue Treatment Using Focused Ultrasound
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
Dr. Nowell Solish Private Office
Toronto, Ontario, Canada
Change from baseline in waist circumference
Time frame: 12 weeks
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time frame: 4 weeks
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time frame: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 1 week
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 4 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 12 weeks
Visual Analog Scale (VAS) diary to record post treatment discomfort.
Time frame: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
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Time frame: 4 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 8 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 12 weeks