ZELTIQ CoolSculpting System, Руководство пользователя

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System Overview ZELTIQ Clinical Studies
User Manual 9
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, Triglycerides, HDL Cholesterol,
LDL Cholesterol, VLDL Cholesterol, Cholesterol/HDL Ratio, Total Protein, Albumin, AST-SGOT, ALT-SGPT, Total
Bilirubin, and Direct Bilirubin. No statistically significant changes were found for serum lipids or liver enzyme
data from baseline over the duration of the study.
BMI Recommendations
For best results, patients should have a BMI of 30 or less and should maintain a healthy lifestyle following a
treatment. The study evaluations for this clinical investigation included subjects with a Body Mass Index up to
38.7; however, patients who are significantly overweight are less likely to appreciate a significant improvement
with a single treatment.
Skin Type
The clinical investigation subject population included Fitzpatrick skin types ranging from I to VI, with the
majority of subjects being types II to IV. No change in skin pigmentation was observed following a treatment.
Based on the clinical data, ZELTIQ recommends that practitioners read this Preface carefully and pay special
attention to warnings and cautions throughout the User Manual and Directions for Use.
Abdominal Study
A separate clinical investigation with the CoolSculpting device on the fat layer of the abdomen resulted in a
clinically measurable reduction of local subcutaneous fat of the abdomen, in the same manner that that was
previously demonstrated for the flank. Treatments were performed at -10°C (CIF 42) for 60 minutes. The
primary endpoint results (Independent Photo Review) revealed that the percent correct identification of the
pre-treatment images exceeded the pre-established 80% criterion and is statistically significant. Fat layer
reduction in the treated area of the abdomen was further documented by ultrasound imaging which also
revealed a statistically significant and clinically relevant reduction. Overall, 62% of subjects enrolled in the
study indicated they were satisfied with the treatment.
Study data also revealed that the treatment is as safe when used in the abdomen as previously tested for the
flank. Data collected during the study demonstrated that the post-treatment lipid profile and liver function
tests showed no statistically significant difference from baseline. This was true for mean values for the entire
population as well as for each individual subject. No serious adverse events were reported during the abdomen
study. The results of this clinical study provide supportive evidence that treatment with the CoolSculpting
device provides consistent and clinically significant reduction of the fat layer of the abdomen.
Summary of Thigh Studies
ZELTIQ conducted two clinical investigations to determine the safety and efficacy of cold-assisted lipolysis in
the thigh region. In the inner thigh study, 90 treatments were completed with the flat cup vacuum applicator at
-10°C (CIF 42); in the outer thigh study, 40 treatments were completed with the belt applicator at -10°C (CIF
23). Follow-up data is available for both studies up to 16 weeks post-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.