CoolSculpting® Elite
System User Manual
ZELTIQ Clinical Studies
CS-UM-CM3-02-EN-D
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Triglycerides, HDL Cholesterol, LDL Cholesterol, VLDL Cholesterol, Cholesterol/HDL Ratio, Total
Protein, Albumin, AST-SGOT, ALT-SGPT, Total Bilirubin, and Direct Bilirubin. No statistically significant
changes were found for serum lipids or liver enzyme data from baseline over the duration of the study.
BMI Recommendations
For best results, patients should have a BMI of 30 or less and should maintain a healthy lifestyle
following a treatment. The study evaluations for this clinical investigation included subjects with a Body
Mass Index up to 38.7; however, patients who are significantly overweight are less likely to appreciate a
significant improvement with a single treatment.
Skin Type
The clinical investigation subject population included Fitzpatrick skin types ranging from I to VI, with the
majority of subjects being types II to IV. No change in skin pigmentation was observed following a
treatment.
Based on the clinical data, ZELTIQ recommends that practitioners read this Preface carefully and pay
special attention to warnings and cautions throughout the User Manual and Instructions for Use.
Abdominal Study
A separate clinical investigation with the CoolSculpting device on the fat layer of the abdomen resulted
in a clinically measurable reduction of local subcutaneous fat of the abdomen, in the same manner that
was previously demonstrated for the flank. Treatments were performed at -10°C (CIF 42) for 60
minutes. The primary endpoint results (Independent Photo Review) revealed that the percent correct
identification of the pre-treatment images exceeded the pre-established 80% criterion and is statistically
significant. Fat layer reduction in the treated area of the abdomen was further documented by
ultrasound imaging which also revealed a statistically significant and clinically relevant reduction.
Overall, 62% of subjects enrolled in the study indicated they were satisfied with the treatment.
Study data also revealed that the treatment is as safe when used in the abdomen as previously tested
for the flank. Data collected during the study demonstrated that the post-treatment lipid profile and liver
function tests showed no statistically significant difference from baseline. This was true for mean values
for the entire population as well as for each individual subject. No serious adverse events were reported
during the abdomen study. The results of this clinical study provide supportive evidence that treatment
with the CoolSculpting device provides consistent and clinically significant reduction of the fat layer of
the abdomen.
Summary of Thigh Studies
ZELTIQ conducted two clinical investigations to determine the safety and efficacy of cold-assisted
lipolysis in the thigh region. In the inner thigh study, 90 treatments were completed with the flat cup
vacuum applicator at -10°C (CIF 42); in the outer thigh study, 40 treatments were completed with the
belt applicator at -10°C (CIF 23). Follow-up data is available for both studies up to 16 weeks post-
