ZELTIQ Clinical Studies
CoolSculpting® Elite
System User Manual
50
CS-UM-CM3-02-EN-D
Table 19: Independent Photo Review Results
Treatment
Group
Number of
Subjects
All Data
% Correct ± % SE
All Data
p-values
All Groups
50
88.6 ± 4.1
< 0.001*
Group 1
20
90.7 ± 5.1
< 0.001*
Group 2
10
90.0 ± 9.5
< 0.005*
Group 3
11
90.9 ± 8.7
< 0.001*
Group 4
9
66.7 ± 15.7
< 0.4
Post-treatment ultrasound measurements of fat layer thickness were compared with baseline
measurements, using the untreated control side to normalize for weight changes that may have
occurred during the follow-up period. The fat layer reduction as measured with ultrasound averaged
18.7% from baseline, after being normalized by the untreated control side. Ultrasound measurements
at two months and at six months indicate that on average, 75% of the total fat layer reduction for a
subject was realized within two months of treatment. Overall, 82.1% of subjects enrolled in the study
indicated they were satisfied with the treatment.
Clinical Safety Results
Reported side effects included pain during or post-treatment, minor or significant bruising of the treated
area, temporary hypoesthesia, tingling, erythema, and edema. All side effects during this study
resolved spontaneously, most resolved within hours or days of the treatment.
Resolution of Hypoesthesia
Partial numbness and, to a lesser extent tingling, over the skin of the application site were reported for
all subjects immediately post-treatment and for 68% of subjects by one week post-treatment. Partial
numbness or tingling is a temporary and anticipated effect of the treatment and was found to resolve
without intervention within two to three weeks on average, although in 8.3% of the cases these effects
endured for as long as two months.
Adverse Events
There were four relatively minor adverse events; each was anticipated and resolved without
intervention. During treatment, two adverse events were reported involving pain and/or discomfort.
Each of these resolved after treatment was discontinued. Following treatment, two adverse events were
reported: severe bruising and minor cramping or muscle spasm in the treatment area. Both resolved
without intervention within four weeks. None of the adverse events reported during this study was
considered serious or unanticipated.
During the clinical investigation, serum lipids and liver enzymes were measured in a subset of 20
subjects at times from 1 week to 12 weeks post-treatment to determine whether the CoolSculpting
treatment had an effect on clinical chemistry. The following analytes were measured: Cholesterol,
