Biomedical Engineering Reference
In-Depth Information
(
A
)
(
B
)
Figure 12.4
Clinical image before (
A
) and results after (
B
) three treatments spaced 1 month apart with nonthermal focused ultrasound (UltraShape).
Source
:
Courtesy of UltraShape, Syneron/Candela.
(
A
)
(
B
)
Figure 12.5
Clinical image before (
A
) and results 12 weeks after (
B
) a treatment with thermal focused ultrasound.
Source
: Liposonix®; courtesy of Solta Medical
Aesthetic Center.
and fl anks. Waist circumference measured before and 3 months
after single treatment was one of the primary outcomes
(Fig. 12.5) (18). The second study treated the abdomen and
fl ank of 85 patients with a single session of HIFU (19). Both
studies reported an average waist circumference reduction of
4.4 and 4.7 cm, respectively. In addition, greater than 70% sub-
ject satisfaction was reported in both studies at 3 months after
treatment. Unfortunately, diet was not controlled in either study.
The seminal study that led to the approval of this device by
FDA for body contouring, was a randomized controlled trial
done by Jewell et al. (20). In this study, 180 patients were ran-
domized to 1:1:1 to two treatment groups with variable
energy levels or sham-treated control group. Primary out-
come measures included waist circumference measured at the
iliac crest. Statistically signifi cant decrease in waist circumfer-
ence in treatment groups when compared with sham-treated
control group was noted at 12 weeks following single treat-
ment. During the study period, patients were instructed to
continue their routine diet and exercise regimen in all treat-
ment groups, and no signifi cant change in body mass was
noted in all treatment groups.
Histologic analysis of tissue from abdominal sites treated
with TFU was obtained from patients who had subsequent
abdominoplasty after TFU treatments. Evaluation of these
