CoolSculpting® Elite
System User Manual
ZELTIQ Clinical Studies
CS-UM-CM3-02-EN-D
49
Table 17: Treatment Efficacy and Safety Assessments
Assessment
Prior to
Day 0
Day 0
Treatment
1 week
2 months
6 months
Consent screening
Baseline demographics
Phone follow-up
Photographs
Ultrasound
Clinical assessment
Four groups were treated with the treatment regimens shown in Table 18. A short period (two to five
minutes) of simultaneous tissue cooling and massage was used during each treatment to facilitate
lipolysis. For each subject, the larger of the two flank bulges was treated, leaving the contralateral side
as an untreated control.
Table 18: Treatment Regimens
Treatment
Group
Number of
Subjects
Cooling
Intensity
Factor (CIF)
Temperature
Cooling
Duration
(minutes)
Energy
Extraction
Rate (mW/cm
2
)
Group 1
28
33
-4ºC
60 min
63.6
Group 2
11
37
-7ºC
30 min
68.3
Group 3
11
37
-7ºC
45 min
68.3
Group 4
10
42
-10°C
30 min
72.9
Clinical Efficacy Results: Blinded Photographic Evaluation
Efficacy was determined by photographic evaluation, ultrasound fat-thickness measurements, clinical
assessments, and subject satisfaction. A blinded photographic evaluation was performed of 50
evaluable subjects in which three blinded reviewers were provided two series of photographs for each
subject, one series taken at baseline, and the other taken post-treatment. Each reviewer was asked to
identify the baseline photo series independently. In the blinded photographic review of all subjects the
reviewers correctly identified the baseline photo series 88.6% of the time.
