ZELTIQ Clinical Studies
CoolSculpting® Elite
System User Manual
48
CS-UM-CM3-02-EN-D
A P P E N D I X A
ZELTIQ Clinical Studies
Note:
When the flank, abdomen, and thigh studies were performed, the degree of cooling or heating
during a treatment was expressed as the Cooling Intensity Factor (CIF). The CIF was an index
that represented the rate of heat flux into or out of tissue relative to 37°C. A positive CIF
described the rate of heat flux out of tissue. A negative CIF referred to the rate of heat flux into
tissue. The studies in this section used the CIF as a unit of measure. Current treatment
parameters refer to the temperature at the surface of the applicator.
The ZELTIQ CoolSculpting System has undergone pre-clinical and clinical investigation (data on file at
ZELTIQ). The clinical investigation and results pertaining to skin cooling for fat layer reduction in
submental and submandibular areas, abdomen, flanks, thighs, and alternate treatment parameters are
summarized in this section.
Table 16 summarizes the efficacy information for each study that has been conducted. Further details
on each study can be found in the individual summaries below.
Table 16: Summary of Study Efficacy
Treatment Site
Photographic Review
Results (% correct)
Ultrasound Results
(mean reduction in mm)
Subject Satisfaction
(% satisfied)
Flanks
88.6
N/A
82.1
Abdomen
85.3
1.9
62
Inner thigh
90.5
2.8
93.3
Outer thigh
83.9
2.5
86.5
Modified treatment
parameters
85
3.92
88.37
Submental Area
91.4
2.0
83.3
Upper Arm
85.2 [72.9%, 93.4%]
3.2
63.3
Flank Study
Assessment Time Line
A clinical study that enrolled 60 healthy adult subjects, aged 23 to 65 years at two clinical centers was
conducted from August 2007 through June 2008. Each individual received one or more applications of
the ZELTIQ CoolSculpting System with a ZELTIQ vacuum applicator. Assessments of treatment
efficacy and safety were performed as follows:
