CoolSculpting® Elite
System User Manual
ZELTIQ Clinical Studies
CS-UM-CM3-02-EN-D
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taken at baseline and at the 16-week follow-up visits were reviewed by a blinded independent panel of
three physicians board-certified in dermatology or plastic surgery. The overall correct identification rate
by the three evaluators was 85%, which exceeded the pre-established 80% criterion and is statistically
significant.
The secondary efficacy endpoint for subject satisfaction was performed by means of a questionnaire
with questions about the comfort and subjective results of the treatment, and about the subject’s
attitudes toward CoolSculpting after treatment. With the exception of comfort, the majority of responses
were positive to very positive. Overall, 88.37% of subjects enrolled in the study indicated they were
satisfied with the treatment.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively
induce cold-assisted lipolysis with colder temperatures down to -15°C for shorter duration treatments
with vacuum and surface applicators.
Submental Area Study
ZELTIQ conducted a clinical investigation to determine the safety and efficacy of the CoolSculpting
System for affecting the appearance of visibly localized subcutaneous fat localized in the submental
area.
In this study, 60 subjects were enrolled at three clinical sites. Sixty initial treatments were performed
with the prototype CoolMini vacuum applicator; 59 subjects were re-treated at the 6-week follow-up
visit. Treatments were performed at -10°C for 60 minutes. Follow-up data is available through 12 weeks
post-treatment. Subject safety was assessed throughout the study.
The primary safety endpoint was the measurement of all device- or procedure-related adverse events.
All adverse events reported during and after the treatment were included in the safety analysis. The
primary safety endpoint was met. No device- or procedure-related serious adverse events (SAE) and
no unanticipated adverse device effects (UADE) occurred during the study. Four device- or procedure-
related adverse events were reported and have resolved. Clinical safety assessment showed
anticipated side-effects, all of which resolved over the course of the study. The safety data recorded
during this study supports the safety of the treatment parameters and device investigated.
The primary efficacy endpoint was correct identification of pre-treatment vs. 12-week post-final
treatment images by 3 blinded independent reviewers. The overall correct identification rate by the 3
reviewers was 91% for the per-protocol population (n=58), which met the pre-established 80% criterion
for success. The primary efficacy endpoint was met.
Reduction in subcutaneous fat layer thickness as measured by ultrasound at 12-weeks post-final
treatment was a secondary efficacy endpoint for this study. Analysis of the per-protocol data (57
subjects) showed a statistically significant (p<0.0001) reduction of 0.20 cm. Therefore, the secondary
efficacy endpoint for reduction of fat layer thickness was met.
The secondary efficacy endpoint for subject satisfaction was assessed by a questionnaire administered
at 12 weeks post-final treatment. Overall, 83.3% of subjects enrolled in the study indicated they were
satisfied with the treatment and 80% reported that they would recommend the treatment to a friend.
