ZELTIQ CoolSculpting System, Руководство пользователя

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ZELTIQ Clinical Studies System Overview
14 BRZ-101-TUM-EN2-L
Reference Treatment Area Placement of the applicator
Treatment
Cycles (n)
Kilmer, Burns, &
Zelickson, 2016
Submental area
Single cycle placed in the center submental
area
119
Leal Silva, Hernandez,
Vazquez, Leal Delgado, &
Blanco, 2017
Submental area
Single cycle placed in the center submental
area
30
Lee, Ibrahim, Arndt, &
Dover, 2018
Submental and
Submandibular
areas
Bilateral treatment cycles with 30% overlap
in the center of the submental area.
Applicator is placed 1 to 2 cm from inferior
aspect of mandible, in sequence.
2
Li, DaSilva, Canfield, &
McDaniel, 2018
Submental and
Submandibular
areas
Single cycle placed in the center submental
area
1
Bilateral treatment cycles with overlap in
the center of the submental area.
2
Suh et al., 2018
Submental and
Submandibular
areas
Bilateral treatment cycles with 30% overlap
in the center of the submental area.
20
Reported safety included common procedural side effects such as erythema, bruising, numbness, edema,
blanching, tingling, increased sensitivity, itching, pigmentation changes, tenderness, and hoarseness, typically
resolving within one month of treatment. It is believed that these side effects are not specifically quantified
and reported in all publications because they are expected, self-resolving, and considered minor; thus, reports
of erythema, bruising, pain, and transient numbness are likely under-reported. From the publications that
reported a total of 228 treatment cycles, the most common side effects at 1-Week post-treatment were
numbness (105 reports), tingling (24), edema (9), and erythema (3 reports).
Several techniques measured effectiveness, techniques including ultrasound measurement, caliper
measurement, Magnetic Resonance Imaging (MRI), three-dimensional (3D) quantification of volume reduction,
patient satisfaction, and blinded, independent review of clinical photographs. The mean ultrasound
measurement of fat layer reduction was 2.4 mm with a range from 2.0 to 2.8 mm. The mean caliper
measurement of fat layer reduction was 3.17 mm (around 33%) with a range from 2.3 to 4.0 mm. The single
study using MRI imaging showed mean reduction of 1.78 mm or 17% subcutaneous fat layer reduction. The
3D imaging showed a mean calculated reduction of 8.5 mL fat volume, and calculated reduction in submental
laxity by 2.25 mm. Three-dimensional volumetric measurement showed a fat reduction of 4.82 cm
3
.
Blinded, independent photo review was conducted in several studies with correct identification of baseline
photographs ranging from 60% to 91%, averaging 77%. Patient satisfaction ranged from 80% to 93%,
averaging 85%.
There were no device or procedure-related serious adverse events related to treatment of the submental and
submandibular areas in the six publications.