Feasibility Study of a Cryolipolysis Surface Applicator for Non-Invasive Fat Reduction in the Outer Thigh

Stevens, W. Grant

Goals/Purpose: Vacuum applicators have been used for cryolipolysis of the abdomen, flanks, inner thighs, back, chest, and arms. The outer thighs, however, have not been easily treated by cryolipolysis because the fat cannot be readily drawn into a vacuum cup. This study investigates feasibility of a cryolipolysis surface applicator for the outer thigh (“saddlebags”).

Methods/Technique: A prototype contoured surface applicator (ZELTIQ Aesthetics, Pleasanton, CA) was used to treat 40 subjects unilaterally on the outer thighs. The study was a prospective, non-randomized, interventional cohort, multi-center clinical study. Treatments were delivered at the default Cooling Intensity Factor (CIF) for 120 minutes with follow-up visits conducted at 8 and 16 weeks. Ultrasound imaging and clinical photography were used to measure fat reduction. Adverse events were monitored to assess procedure and device safety. Self-assessment questionnaires were completed.

Results/Complications: Interim data is presented for n=26 subjects that completed 16 week follow-up. Independent photo review from 3 blinded physicians found 81% correct identification of baseline and post-treatment clinical photographs. Ultrasound data indicate a significant reduction in fat thickness when compared to the untreated control thigh. Patient questionnaires reveal 85% would recommend CoolSculpting to a friend; 81% were satisfied with the CoolSculpting procedure for the outer thighs; 81% noticed visible fat reduction in the treated area; 81% found the procedure comfortable; and 96% were likely to have a second treatment. There were no serious adverse events or unanticipated adverse device effects.

Conclusion: The prototype contoured surface cryolipolysis applicator provided safe and efficacious treatment to outer thigh fat. Interim 16-week data shows clinically significant reduction in fat thickness. Assessment of clinical photographs found 81% correct identification of baseline images. Full safety and efficacy data will be presented for all n=40 study subjects at the conference.