ZELTIQ Clinical Studies
CoolSculpting® Elite
System User Manual
52
CS-UM-CM3-02-EN-D
treatment. Three blinded evaluators assessed the photos for visible reduction of fat in the treatment
areas at the 16-week follow-up visit. The evaluators were presented with the series of photographs and
were asked to identify the pre-treatment photographs for each subject.
The overall correct identification rate by the three evaluators was 90.5% for the inner thigh study and
83.9% for the outer thigh study. At least two out of three evaluators correctly identified 90.5% of all
photo pairs for the inner thigh study and 87.1% for the outer thigh study. The results demonstrate that
the ZELTIQ CoolSculpting System affects the appearance of the thighs.
Change in subcutaneous fat layer thickness was also measured by ultrasound at 16 weeks: In the inner
thigh study average fat thickness change was a 2.8 mm decrease. In the outer thigh study average fat
thickness change was a 2.5 mm decrease. Overall for the inner thigh study, 93.3% of subjects enrolled
in the study indicated they were satisfied with the treatment. Overall for the outer thigh study, 86.5% of
subjects enrolled in the study indicated they were satisfied with the treatment.
Adverse events reported during the studies included numbness and mild contour irregularity. All
adverse events but one resolved by the 16-week follow-up. A mild case of hyperpigmentation in the
treatment area persisted beyond the 16-week follow-up. This is an adverse event that typically resolves
spontaneously. The clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System
can safely and effectively induce cold-assisted lipolysis in the thigh in the same manner as in the
abdomen and flanks.
Summary of Study with Modified Treatment Parameters
A study of a modified treatment parameter was designed to evaluate the safety and efficacy of the
CoolSculpting System with a colder, shorter treatment. In this study, 63 treatments were completed with
the Co applicator on 45 subjects. Each subject received one or two non-overlapping unilateral
vacuum treatments of the flank at a treatment temperature of -15°C for 45 minutes; immediately after
each treatment, the treated tissue was massaged manually for two minutes. Follow-up data is available
for up to 16 weeks post-treatment.
Subject safety was assessed throughout the study, including immediately post-treatment, one-week
post-treatment telephone follow-up, and at 8- and 16-week post-treatment clinic visits. The primary
safety endpoint was the occurrence of device- or procedure-related adverse events. No serious
adverse events were reported during the study or 16-week follow-up period. Adverse events reported
during the study included mild numbness, post-treatment pain, hyperpigmentation, subcutaneous
induration, and first-degree burn in the treatment area. All but three adverse events resolved by the 16-
week follow-up. Three subjects reported mild numbness at the 16-week follow-up; all three reported
resolution within the next 19 calendar days.
The primary efficacy endpoint was the change in fat layer thickness as measured with ultrasound. Fat
layer reduction in the treated area of the flank was documented by ultrasound imaging pre-treatment
and at 8 and 16 weeks post-treatment. Subsequent evaluation of the ultrasound images revealed a
statistically significant and clinically relevant reduction.
Secondary efficacy endpoints included correct identification of pre- and post-treatment images by three
blinded independent reviewers, and subject satisfaction assessment by subject questionnaire. Photos
