ABSTRACT
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.
ABSTRACT
Toxoplasma gondii is an obligate intracellular parasite belonging to the phylum Apicomplexa, which causes the zoonotic disease toxoplasmosis. T. gondii infects almost all warm blood animals. Generally, infected animals are asymptomatic and remain infected for life. Infection of humans occurs by consumption of infected undercooked meat or contaminated vegetables, fruit and water. The aim of this study was to evaluate the prevalence and seroprevalence of T. gondii in livestock in Israel. For the serological screening we investigated the presence of antibodies against T. gondii in sera using the indirect fluorescent antibody test (IFAT). Molecular screening was preformed using conventional PCR and nested PCR for the detection of T. gondii DNA in tissue samples. Serum samples of 249 cattle and 138 sheep were collected from farms. This serological survey showed high seroprevalence with seropositivity of 29 % in cattle and 33 % in sheep. In addition, 526 paired sera and tissue samples from cattle, sheep and pigs were obtained in slaughterhouses. The serological prevalence of T. gondii in healthy animals intended for human consumption was 29.4 % in cattle, 26.1 % in sheep and 8.1 % in pigs. The molecular detection of T. gondii in the tissue samples was 7.5 % in cattle, 7.3 % in sheep and 6.3 % in pigs. Considering the combined positive results from both serological and molecular assays, exposure to or infection with the parasite was present in 26.2 % of the samples (33.8 % in cattle, 30.3 % in sheep, 12.5 % in pigs). The prevalence of T. gondii in pigs was significantly lower compared to that of cattle and sheep (P < 0.001). All PCR positive samples from animals and 12 human positive samples were genotyped using a restriction fragment length polymorphism (PCR-RFLP) method. The results showed the existence of atypical genotypes in the majority of the samples and no correlation between animals and human samples could be determined from this study. Widespread exposure to T. gondii in Israel with the presence of parasite DNA in meat from cattle, sheep and pigs meant for human consumption was found.
