Cryolipolysis Treatment to Transformation: One Year Safety and Efficacy Follow-up
Methods/Technique: In a multi-center study, n=26 subjects received cryolipolysis treatment (CoolSculpting, ZELTIQ Aesthetics, Pleasanton, CA) in the abdomen, flanks, back, arm, inner thighs, knees, and chest. Follow-up visits took place 2- and 4-months post-treatment to evaluate side effects and efficacy. At 2-months, additional treatments were delivered to new areas or repeat treatments were given to the same sites. Approximately 1 year post-treatment, available subjects returned for follow-up with ultrasound measurements, clinical photographs, and self-assessment questionnaires.
Results/Complications: One-year follow-up is currently in progress. Interim ultrasound results show appreciable reduction in fat layer thickness. Questionnaires indicated high patient satisfaction, visible fat reduction, procedural tolerability, and desire to have additional CoolSculpting treatments. Blinded, independent photographic review found high incidence of correct identification of baseline images.
Conclusion: To the best of the investigators’ knowledge, this is the first report of long-term safety, efficacy, and satisfaction for cryolipolysis T2T patients. The T2T treatment approach was designed to deliver cryolipolysis to multiple sites to achieve global fat reduction, optimized clinical outcomes, and increased patient satisfaction. From 4 clinical study sites treating 26 patients, this study investigated treatment to the abdomen, flanks, arms, inner thighs, chest, knees, and back. No serious adverse events were reported. Long-term fat layer reduction was achieved over multiple treatment areas, yielding high patient satisfaction.