RESUMO
OBJECTIVES: This study aims to assess the thermal safety profile of the BeShape One Device, a noninvasive, high-intensity, non-focused ultrasound device designed for reducing waist circumference. This device possesses several features that distinguish it from other commercial ultrasound-based fat reduction devices. The study focuses on evaluating temperature-related physiological changes through thermal safety analysis and histopathology in a swine model. MATERIALS AND METHODS: The study utilized three types of applicators-active, demo, and modified-to comprehensively assess the device's impact on various skin layers. Five female Large White X Landrace swine were involved in the study, and the BeShape One Device was applied to designated treatment sites using a specific treatment protocol. The assessment included clinical observations, skin reaction evaluations, gross pathology, histopathological analyses, and advanced temperature measurement techniques, including needle thermocouples, thermal cameras, COMSOL modeling, and CEM43 analysis. RESULTS: Clinical observations indicated the animals' overall well-being throughout the study. Skin reactions, including erythema, edema, bruising, and crust formation, were temporary and resolved over time. Gross pathology revealed no treatment-related pathologies, except for a discoloration related to a tattoo procedure. Histopathological analyses at 30 and 90 days posttreatment demonstrated an absence of heat-related lesions in skin layers. Needle thermocouples and thermal camera measurements supported the device's ability to maintain consistent thermal homogeneity. COMSOL modeling and CEM43 analysis predicted no thermal damage to the skin, confirming the safety of the BeShape One Device. CONCLUSIONS: Under the experimental conditions, the BeShape One Device demonstrated a favorable safety profile. Clinically and histopathologically, no adverse effects were observed. The device's ability to achieve thermal homogeneity in skin layers was validated through advanced temperature measurement techniques. COMSOL modeling and CEM43 analysis further supported the conclusion that the device is safe, making it a promising option for noninvasive body contouring procedures.