System Overview
ZELTIQ Clinical Studies
User Manual
13
Summary of Clinical Study Publications
A review of clinical publications revealed 4,792 cryolipolysis treatments during clinical studies. From these
studies, we compiled the numbers of treatments in several anatomical areas: 1,695 treatments in the
abdomen, 1,987 treatments in the flanks, 501 treatments in the back, 323 treatments in the inner thigh, 150
treatments in the lateral thigh, 3 treatments in the anterior thigh, 119 treatments in the submental area, and
14 treatments in the banana roll region.
Efficacy was measured by several techniques including ultrasound and caliper measurements, circumferential
measurements, 3D quantification of volume reduction, and blinded, independent review of clinical
photographs. Based on the compilation of data from these studies, the overall mean ultrasound fat layer
reduction ranged from 10.3 to 25.5% and 1.9 to 8.3 mm.
Compiled mean caliper fat layer reduction ranged from 14.7 to 23.0%. Single studies showed mean 0.9 cm
circumferential reduction in the inner thigh, 2.4 cm circumferential reduction in the flanks, 6.8 cm
circumferential reduction in the abdomen, and 39.6 cm3 volumetric reduction in the flanks.
Based on the compilation of these various studies, the overall mean ultrasound fat layer thickness reduction
was 20.6% and 3.9 mm. Compiled mean caliper fat layer reduction was 22.3%. The independent photo review
was 89.7% correct, on average.
As shown by multiple clinical studies submitted for clearance to the agency, the summary of published data
shows a similarly high safety and efficacy profile for the cryolipolysis procedure. Common procedural side
effects include erythema, bruising, and numbness, which typically resolve within one month of treatment.
Based on the literature review, 6 cases would be considered serious adverse events. These serious adverse
events include three cases of paradoxical hyperplasia in the abdomen, one case of paradoxical hyperplasia in
the abdomen, back, and flanks, one case of contour irregularity in the abdomen, and one case of contour
irregularity in the flank. For 4,792 treatments in published studies, the incidence of serious adverse events is
very low (0.13%). Given the fact that 76.8% of treatments were to the abdomen and flanks, this incidence rate
shows no clear indication of treatment site specificity. The clinical publications indicate that cryolipolysis is a
safe and effective non-surgical procedure for subcutaneous fat reduction.
Summary of Clinical Study Publications for the Submental and Submandibular Areas
Six clinical publications reported safety and effectiveness of 228 cryolipolysis treatments in 102 patients to
include 89 patients with a Body Mass Index (BMI) of up to 46.2 and 27 patients treated in the submental and
submandibular areas.
Literature review of cryolipolysis indicates that clinicians are currently treating below the entire mandible,
including both the submental and submandibular areas, in order to achieve best aesthetic outcome. See Table
1 which summarizes the applicator placement methods tabulated from the six publications. Two applicator
placement approaches are identified: single cycle placed in the center submental area, as well as two cycles
covering the bilateral submandibular area, with a 20
–
30% overlap in the center submental area. demonstrates
a typical two-cycle placement method treating submental and submandibular areas.
Reference
Treatment Area
Placement of the applicator
Treatment
Cycles (n)
Bernstein & Bloom, 2017
Submental and
Submandibular
areas
Bilateral treatment cycles with 20% overlap
in the center of the submental area.
52
Single cycle placed in the center submental
area
2
