System Overview
ZELTIQ Clinical Studies
User Manual
7
NOTE: When the flank, abdomen, and thigh studies were performed, the degree of cooling or warming 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.
The below table summarizes the efficacy information for each study that has been conducted. Further details
on each study can be found in the individual summaries below.
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:
Day 0 Treatment
1 Week
2 Months
6 Months
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Four groups were treated with the treatment regimens shown in Table 3. A short period (two to five minutes)
of simultaneous tissue cooling and massage was used during each treatment to facilitate lipolysis. For each
subject, the larger of the two flank bulges was treated, leaving the contralateral side as an untreated control.
