ZELTIQ CoolSculpting System, Руководство пользователя

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ZELTIQ Clinical Studies System Overview
10 BRZ-101-TUM-EN2-L
The overall correct identification rate by the three evaluators was 90.5% for the inner thigh study and 83.9%
for the outer thigh study. At least two out of three evaluators correctly identified 90.5% of all photo pairs for
the inner thigh study and 87.1% for the outer thigh study. The results demonstrate that the ZELTIQ
CoolSculpting System affects the appearance of the thighs.
Change in subcutaneous fat layer thickness was also measured by ultrasound at 16-weeks: In the inner thigh
study average fat thickness change was a 2.7 mm decrease. In the outer thigh study average fat thickness
change was a 2.6 mm decrease. Overall for the inner thigh study, 93.3% of subjects enrolled in the study
indicated they were satisfied with the treatment. Overall for the outer thigh study, 86.5% of subjects enrolled
in the study indicated they were satisfied with the treatment.
Adverse events reported during the studies included numbness and mild contour irregularity. All adverse
events but one resolved by the 16 week follow-up. A mild case of hyperpigmentation in the treatment area
persisted beyond the 16 week follow-up. This is an adverse event that typically resolves spontaneously. The
clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System can safely and effectively
induce cold-assisted lipolysis in the thigh in the same manner as in the abdomen and flanks.
Summary of Study with Modified Treatment Parameters
A study of a modified treatment parameter was designed to evaluate the safety and efficacy of the
CoolSculpting System with a colder, shorter treatment. In this study, 63 treatments were completed with the
Co applicator on 45 subjects. Each subject received one or two non-overlapping unilateral vacuum
treatments of the flank at a treatment temperature of -15°C for 45 minutes; immediately after each treatment,
the treated tissue was massaged manually for two minutes. Follow-up data is available for up to 16 weeks post-
treatment.
Subject safety was assessed throughout the study, including immediately post-treatment, one-week post-
treatment telephone follow-up, and at 8- and 16-week post-treatment clinic visits. The primary safety endpoint
was the occurrence of device- or procedure-related adverse events. No serious adverse events were reported
during the study or 16-week follow-up period. Adverse events reported during the study included mild
numbness, post-treatment pain, hyperpigmentation, subcutaneous induration, and first-degree burn in the
treatment area. All but three adverse events resolved by the 16 week follow-up. Three subjects reported mild
numbness at the 16-week follow-up; all three reported resolution within the next 19 calendar days.
The primary efficacy endpoint was the change in fat layer thickness as measured with ultrasound. Fat layer
reduction in the treated area of the flank was documented by ultrasound imaging pre-treatment and at 8 and
16 weeks post-treatment. Subsequent evaluation of the ultrasound images revealed a statistically significant
and clinically relevant reduction.
Secondary efficacy endpoints included correct identification of pre- and post-treatment images by three
blinded independent reviewers, and subject satisfaction assessment by subject questionnaire. Photos 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.