Background
Patient-reported outcome (PRO) data evaluating the physical and psychosocial impact of Cryolipolysis (CoolSculpting) treatment are limited.
Objectives
Assess multidimensional aspects of satisfaction following cryolipolysis treatment of the flanks and abdomen using a combination of PRO instruments.
Methods
This was a multi-national, prospective, single cohort, interventional study. The primary endpoint was the proportion of Satisfied or Very Satisfied participants with treatment at 12 weeks post final treatment. Secondary endpoints included satisfaction categorized by treatment area, total number of treatment cycles, baseline body mass index (BMI), and fat volume reduction measured by 3D photography at 12 weeks post final treatment. Exploratory endpoints assessed the physical and psychosocial impacts of treatment. Safety was monitored throughout the study.
Results
Of 112 participants who were treated, 74.1% were female. The mean age and BMI were 42.5 years and 24.9 kg/mg 2, respectively. Of the 106 evaluable participants, 89.6% were Satisfied or Very Satisfied with treatment results. Satisfaction was high regardless of body area(s), total number of treatment cycles, or baseline BMI. Mean (SD) fat volume reduction was 264.8 mL (411.4). Overall, 90.6% reported Noticeable or Very Noticeable fat reduction, 89.6% were Likely or Very Likely to treat additional areas, and 93.4% would recommend cryolipolysis to a friend. 24 (21.4%) participants reported treatment-emergent adverse events (AEs); 23 (20.5%) reported these as Adverse Device Effects (ADE). No serious device-related or unanticipated adverse effects occurred.
Conclusions
Cryolipolysis (CoolSculpting) for fat reduction of the flanks and/or abdomen was well-tolerated and associated with high levels of satisfaction across multidimensional PROs.
