Evaluation of the activity

of a medical device for cavitational

ultrasound lipolysis

SU M M A R Y Evaluation of the activity

Adele Sparavigna
of a medical device for cavitational
ultrasound lipolysis
Nowadays there is wide discussion about the possible medical applications of focused
ultrasound in minimally invasive treatment of a variety of disorders and diseases.
One possible application of focused ultrasound is lipolysis. This new technique is of
great interest especially for those patients who do not intend to undergo invasive
treatment for localized fat accumulation. The biological effect of ultrasound useful
for this purpose is cavitation. We have conducted a clinical study on the effect of a
treatment based on cavitational ultrasound on localized fat accumulation.

KEY WORDS: Focused ultrasound, Lipolysis, Cavitation

Basic concepts
Ultrasonic vibrations spread in the
form of a wave in an elastic medium such as a liq-
uid or a solid. When the particles of the medium
are under vibration, they act in only one direc-
tion. The obtained ultrasound wave spreads in
one direction and is continuous. Ultrasound can
be divided into: very low frequency (20-100
KHz), low frequency (100 KHz - 1 MHz), high
frequency (1-10 MHz). The lipolytic range of
ultrasounds is 30-70 KHz, but best results are
obtained in a more restricted range: 30-35 KHz.
The depth of the treatment in the tissues is gen-
erally 2-3 cm, in order to avoid muscles involve-
ment. Biological effects of ultrasounds on
adipocytes are:
1) micromechanical: depolymerisation or molec-
ular dissociation of the triglycerides which
increase their fluidity;
2) thermal: ultrasounds determine molecolar
movement producing cinetical energy of the
molecules which results in an increase of tem-
perature;
3) microstreaming (sound effect);
4) cavitation: in a fluid ultrasounds produce an
alternation of decompression and compres-
sion waves, which progressively increase the
tension of the adipocyte until it implodes and
frees the emulsified fat.
Derming, Clinical Research
and Bioengineering Institute, Monza, Italy
Based on these effects, high power acoustic
waves, if precisely targeted and controlled in
amplitude, may exert the following effects on fat
tissue: lipolysis or ejection of fat acids from the
adipocyte due to the cavitation phenomena and
to the membrane permeability increase of the
adipocyte; reduction of fibrosis due to mechani-
cal action exerted on the connective tissue in the
hypodermis. The device used for our study has a
peculiarity, the “built in feedback”, able to calibrate
the emission depth on the thickness of adipous
panniculus.
MethTood evaluate the efficacy of an ultra-
sound cavitational device* on subjects with local-
ized adiposity on the thighs (trochanteric region),
a clinical study was conducted on 20 female
healthy subjects, age range 18-53 years (mean =
42) whose informed consent had been obtained.
In particular volunteers were divided into 2
experimental groups of 10 subjects:
Group I with subcutaneous infiltration - the
subjects, before each treatment session, were
*Genex S3 Lipothermae, Lisifat

Journal of Plastic Dermatology 2008; 4, 2 149

 A. Sparavigna

infiltrated at the level of treated area with 1%
c a rnitine in 20 cc of physiological solution (10
cc/side).
Group II without infiltration - the subjects
u n d e rwent directly to the treatment with the
device.
The trial foresaw 4 treatments with the device (1
treatment/week) for a total of 25 minutes: 5 min-
utes of “f i rm i n g” action (device intensity: 70%)
followed by 20 minutes of “modelling” action
(device intensity: 80%).
Morphometrical (circumferences measurements)
and instrumental evaluations (body weight, skin-
fold caliber) were performed according to the fol-
lowing scheme:
T0 (baseline evaluation): before the 1st treatment
T1 (intermediate evaluation): 1 week after the
1st treatment and before 2nd treatment
T4 (final evaluation): 1 week after the 4th treat-
ment.
physical activity), participation in a similar
study during the previous 6 months, insuffi-
cient adhesion to the study protocol, dermato-
logical disease, clinical and significant skin con-
dition on the test area (e.g. lesions, scars, mal-
formations), general disease, pharmacological
treatments.
Results
Statistical analysis
No drop-out occurred, so statistical
evaluation of data was carried out, following
our internal procedures (descriptive and infer-
ential analysis), on a total of 10 persons for each
group.
Instrumental results were submitted to statisti-
cal parametric test.

In addition, at T0 and T4, for each volunteer, the

110,00
impedance was evaluated directly by the device. 107,35
105,95
105,00 104,09
Volunteers 101,2
The study was carried out on 20 99,45
100,00 98,07
informed, healthy, female volunteers with local-
ized adipose panniculus on the thighs.
95,00
Inclusion criteria were: female sex, between 18
and 50 years of age, with localized adipose pan- 90,00
niculus on the thighs, normal routine blood
analysis including triglycerides and cholesterol,
85,00
giving a written informed consent.
Non inclusion criteria: pregnancy, lactation,
80,00
oral contraceptive therapy started less than 1 Group 1 (with infiltration) Group 2 (without infiltration)
year ago, use of any product or weight-loss T0 (basal) T1 (1 week after the 1st treatment) T4 (1 week after the 4th treatment)
treatment (manual or instrumental) during the
last month and for all the duration of the treat- Figura 1. Reduction of circumferences at level of the hips in the two study groups.
ment, change in the normal habits (unusual The comparisons are statistically significant.

150 Journal of Plastic Dermatology 2008; 4, 2


In particular, regarding circumference measure-
ments and skinfold caliber on the treated area:
comparison for each group of T1-T4 results vs
basal conditions (ANOVA test for repeated
measure followed in case of positivity by
Dunnett test);
comparison of the 2 groups at equivalent time
points (standard two samples t test).
Regarding impedence and skinfold caliber on
subscapular fold control area:
comparison for each group of T4 results vs
basal conditions (paired T-test);
comparison of the 2 groups at equivalent
times point (standard two samples T test).
Variations in the adiposity
At T0, T1 and T4 visit subjects’ weight
was recorded. Moreover, to assess eventual vari-
ations of the fat mass percentage, at T0 (basal
visit) and T4 (end of the study) the investigator
m e a s u red for each subject the impedance (pro-
vided by the same device under study) and the
thickness at the level of subscapular untreated
c o n t rol area (with the skinfold caliber). No
important variation of subject’s weight was
noticed at any study time, except for one volun-
teer whose weight at T4 was 2,5 Kg less than the
basal one; in any case these results were not
excluded from the statistical analysis because no
important variation of the subject’s fat mass per-
centage was found. The measure of the sub-
scapular fold resulted to be more reliable than
the impedance measurement; in fact even if any
method showed statistically significant differ-
47,00 46,9
46,00
45,00 44,4
44,00
43,3
43,00
41,9
42,00
41,00
40,3
40,00
Group 1 (with infiltration) Group 2 (without infiltration)
T0 (basal) T1 (1 week after the 1st treatment) T4 (1 week after the 4th treatment)
Figura 2. Reduction of the skin folds at the level of the thighs in the two study groups.
The comparisons are statistically significant.
Evaluation of the activity of a medical device for cavitational ultrasound lipolysis
ences at any study times and between study
groups the measure obtained with the skinfold
caliber was more linear for all subjects (as
showed by the little standard deviation) while
the impedance measure showed a wide standard
deviation in both groups and at all considered
study times.
Morphometric evaluations
Circumferences measurements were
performed at the level of hips and mono-later-
ally (left or right leg according to a predisposed
randomisation list) at the level of the superior
third of the thigh (greater trochanter), thanks to
a specific electro-optical system able to fix the
volunteer’s position.
Morphometrical evaluations at the level of the
thighs underlined, at the end of the treatment,
a statistically significant reduction of thigh cir-
cumference (Dunnett test p <0.05 T0 vs T4) in
both experimental groups (with or without
infiltrations) corresponding respectively to 1.43
cm (mean value) for group I and 1.36 cm
(mean value) for group II, confirming the sig-
nificant results obtained just after the first treat-
ment (Dunnett test p <0.05 T0 vs T1 for both
groups).
No important statistically difference was showed
between the 2 groups at any study times.
At level of the hips the reduction was even more
evident and always statistically significant
(Dunnett test p < 0.05 T0 vs T1 -T4 for both
groups); subjects enclosed in group I reduced
on average 1,76 cm after the first session and
3.14 cm at the end of the treatment, while sub-
jects enclosed in group II reduced on average
1.4 cm after the first treatment and 3,26 cm at
the end of the study period (Figure 1).
An important statistically significant difference
was shown between the 2 groups at all study
times; this gap was not considered clinically
important because the 6,22 cm of difference
(mean value) between the 2 groups kept on
during all the study.
Skinfold caliber
The skinfold caliber was used to mea-
40,6 sure the thickness of the skin tissue layer dire c t-
ly on the adipose panniculus where the tre a t-
ment with the device was performed (mono-lat-
erally on the same leg where circumferences
evaluations were taken).
On subjects who underwent infiltrations before
the treatment the panniculus thickness statisti-
Journal of Plastic Dermatology 2008; 4, 2 151
 A. Sparavigna
cally significant reduced yet after the first session
(Dunnett test T0 vs T1 p <0.05 with a reduction
percentage of 10.7%). T4 results confirmed this
trend with a statistically significant reduction of
14.1% (Dunnett test T0 vs T4 p <0.05).
C o n c e rning subjects who did not receive infil-
trations, the panniculus reduction resulted less
important (-2.5%), after the first treatment and
it did non achieve a statisticaly significance. On
the contrary, at the end of the study period the
panniculus was significantly reduced (Dunnett
test T0 vs T4 p <0.05; -8.6%, Figure 2).
For the second group the panniculus reduction
seems to be less important than the first one, but
in any case no statistically important difference
was shown between the 2 groups at any study
time.
Efficacy evaluation by the volunteers
Adipose panniculus
Group I: 90% of subjects noticed a medium-
marked reduction of the panniculus (20%
marked; 70% medium).
Group II: 70% of subjects underlined a medium
- very marked reduction (10% very marked;
50% marked; 10% medium).
Thigh circumference
Group I: 70% of volunteers noticed a medium -
marked circumference reduction (10% marked;
60% very marked).
Group II: 70% of volunteers underlined a medi-
um - very marked reduction (10% very marked;
40% marked; 20% medium).
Thigh silhouette
Group I: 80% of volunteers underlined a medi-
um - marked improvement of the thigh silhou-
ette (10% marked; 70% very marked).
Group II: 70% of subjects noticed a medium -
v e ry marked improvement (10% very marked;
30% marked; 30% medium).
C o n c e rning skin firmness, 30% of volunteers
belonging to group I referred a medium -
marked improvement of skin firmness versus
60% of subjects belonging to group II (10% very
marked; 20% marked; 30% medium).
Tolerability evaluation
No adverse event/reaction related or
unrelated to the treatment occurred during the
trial. The volunteers judged the treatment toler-
ability good/excellent (group I: 40% good - 60%
excellent; group II: 100% excellent) as con-
firmed by the investigator at the end of the tre a t-
ment period.
152 Journal of Plastic Dermatology 2008; 4, 2
Conclusions
Final results showed that the treatment
with the ultrasound medical device under study
determined a clinically relevant and statistically
significant reduction of the adipose panniculus in
terms of measurement reduction on both treated
groups, confirming the results obtained just after
a single session. Regarding skinfold caliber mea-
surement, it is possible to notice a more marked
reduction of subcutaneous tissue on subjects who
underwent subcutaneous infiltrations.
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