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Barel et al. Ultrasound body contouring

variability, it terms of skin quality and elasticity, the power output and the magnitude of the effect.
can have an effect. In addition, circumference An interesting finding was a minimal increase of
measurement is a rather crude measurement. None of thigh circumference in some groups. It is unclear if
the patients underwent prior liposuction, and therefore beginning a process of body contouring encourages
no comparison can be made with invasive body patients to change their life-style to achieve better
contouring of any kind. Another important factor is that overall results, or if it permits them to continue their
patient’s lifestyle effect was not a part of this study; current habits while relying on technology to correct
the only control was weight and thigh circumference. excessive food intake and a lack of physical activity.
No strict protocol for diet and physical activity was The low number of adverse events in our cohort is
taken into consideration. A final item for consideration consistent with the high safety profile of the device
is that study-related patient satisfaction in aesthetic reported in extensive pre-clinical [10] and clinical
procedures may not be comparable to real-life data studies. [11-14]
from patients who have actually paid for the procedure.
Subjective feelings of the patients play a critical role
The findings indicate that both power levels, with 3 in the outcome of aesthetic procedures, aside from
treatment sessions, led to a statistically significant objective evidence of the safety and effectiveness.
reduction in circumference of the treated area Therefore, subjects completed a questionnaire
relative to baseline. Reductions were noted after evaluating their satisfaction with the results as well as
each treatment session and overall, after all sessions the perception of others. Less than half the subjects in
were completed. The high-power setting was more both groups noted a favorable visible change following
effective than the low-power setting in reducing the the first treatment. However, on later follow-up visits,
circumference of the treated area after the 1st session those rates nearly doubled.
and after the 3rd session.
In summary, multiple treatments over time with the
As mentioned, both study groups showed a statistically Contour I™ device lead to a cumulative reduction in
significant reduction in circumference of the treated abdominal circumference. The effect is greater when
area compared to baseline at all time points, with the high acoustic power is used. Patient satisfaction was
exception of the low-power group on day 14 (P = 0.113). found to be related to the measured circumference
Our assumption is that this data results from tissue reduction. The findings support the use of the
edema. noninvasive Contour I™ as a safe, painless non-
invasive means for body contouring with proven efficacy
The decision to use circumference measurement only, in circumference reduction, correlated to the power of
and not imaging studies, was based on two reasons. ultrasonic energy delivered. Due to the limitation of the
First, subjects normally measure their circumference study, more studies, comparing different modalities in
by wearing trousers or skirts, and the aim of the non-invasive body contouring, are needed. Objective
treatment is to produce erect posture contouring. non-positional related measurements in form of
Secondly, the supine posture in magnetic resonance accurate three-dimensional photography with volume
imaging or ultrasound scan does not correlate exactly calculation may be of future assistance.
with circumference measurement in the erect position
since fat distributes differently in the supine position. Financial support and sponsorship
®
Later studies done by Ultrashape have failed to The study was supported by Ultrashape , Syneron .
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show a significant correlation between these two The study sponsors participated in study design and
measurements. analysis of data.
To isolate the net effect of the device on the specific Conflicts of interest
area treated and to eliminate the possibility of bias There are no conflicts of interest.
in the interpretation of the results, the circumference
of the untreated thighs from each subject was used Patient consent
as an internal control. The results showed that
the reduction in circumference of the treated area Informed consent was obtained from participants.
relative to the untreated area (true net effect) was
statistically significant at all-time points. This finding Ethics approval
was supported by the cumulative effect of the multiple The study was approved by the Helsinki Committee
treatments on the reduction in circumference of of Rabin Medical Center and Sackler Faculty of
the treated area as well as the correlation between Medicine, Tel Aviv University.
Plastic and Aesthetic Research ¦ Volume 3 ¦ December 14, 2016 373