ZELTIQ Clinical Studies
CoolSculpting® Elite
System User Manual
54
CS-UM-CM3-02-EN-D
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively
affect the appearance of visible fat bulges in the submental area with treatment at -10°C for 60 minutes.
Summary of Upper Arm Study
ZELTIQ conducted a clinical investigation to evaluate the safety and efficacy of cryolipolysis for non-
invasive reduction of upper-arm fat.
In this study, 30 subjects were enrolled at two clinical sites. Sixty initial treatments were performed with
a prototype of the CoolAdvantage applicator (CoolFit with aluminum Insert). Each subject was treated
once on each upper arm, at -11°C for 35 minutes. Follow-up data is available through 12 weeks post-
treatment. Subject safety was assessed throughout the study.
The primary safety endpoint was the incidence of unanticipated adverse device effects. Clinical safety
assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting
greater than 12 weeks. No unanticipated adverse device effects, or serious device- or procedure-
related adverse effects occurred. All device- and/or procedure-related adverse events resolved
spontaneously. The primary safety endpoint was met.
The primary efficacy endpoint involved independent panel review of pre- and 12-week post-treatment
photographs of the treatment area for discernible fat layer reduction. The per protocol population
consisted of all the treated subjects followed for 12 weeks with weight change of no more than 5% of
total body weight at the time the 12-week images were taken. For the per protocol population, the
correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%,
93.4%].
Further evidence of treatment efficacy is found in the data from ultrasound measurements of fat
reduction at the treated areas, with significant reduction in the fat layer (0.32 cm) from baseline to 12
weeks post-treatment.
The secondary efficacy endpoint for subject satisfaction was assessed by an IRB-approved
questionnaire administered at 12 weeks post-treatment. 72.41% of the subjects found the procedure to
be comfortable to very comfortable, and 63.3% of the subjects reported that they would recommend the
procedure to a friend.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively
affect the appearance of visible fat bulges in the upper arm area with treatment at -11°C for 35 minutes.
Summary of Submental Area Study
A prior study (ZA14-002), approved by the Food and Drug Administration (FDA) under IDE G140083,
reported the efficacy of cryolipolysis for non-invasive reduction of submental fat. Subsequently, a
retrospective study was carried out in which standardized, masked, photographic images from the
original ZELTIQ-sponsored clinical study were evaluated quantitatively to determine the efficacy of the
CoolSculpting treatment in affecting the appearance of lax tissue in the submental area.
