Safety and Tolerability of High-Intensity Focused Ultrasonography for Noninvasive Body Sculpting: 24-Week Data From a Randomized, Sham-Controlled Study
| Autor: | Joel Schlessinger, Richard G. Glogau, Patrick Martin, Lisa Donofrio, Michael A. C. Kane, Ira Lawrence, Richard A. Baxter, Robert A. Weiss, Mark L. Jewell, Sue Ellen Cox, Jeffrey S. Dover |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors medicine.medical_treatment Ecchymosis Physical examination Cosmetic Techniques Edema medicine Humans Single-Blind Method Ultrasonography medicine.diagnostic_test business.industry General Medicine Middle Aged Subcutaneous Fat Abdominal High-intensity focused ultrasound medicine.anatomical_structure Tolerability Body contouring High-Intensity Focused Ultrasound Ablation Abdomen Female Surgery Radiology Liver function Waist Circumference medicine.symptom business Follow-Up Studies |
| Zdroj: | Aesthetic Surgery Journal. 32:868-876 |
| ISSN: | 1527-330X 1090-820X |
| Popis: | Background: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. Objectives: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. Methods: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm2 (141 J/cm2 total), 59 J/cm2 (177 J/cm2 total), or 0 J/cm2 (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. Results: Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. Conclusions: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels. Level of Evidence: 2 ![Graphic][1] [1]: /embed/inline-graphic-1.gif |
| Databáze: | OpenAIRE |
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