Preclinical and clinical evaluation on the performance and safety of a novel energy‐based device for body shaping: A pilot study

Background The emergence on the market of non‐invasive mechanisms aimed at reducing subcutaneous fat achieving a slimming effect arouses great interest in doctors and patients. Several methods for the destruction of adipocytes are today on the market. Aims This is a pilot study on body fat reduction treatment, using a novel energy‐based device for body shaping. Methods The study is performed on 42 patients, healthy adults of both sexes, with BMI between 25 and 30 kg/m², indicated for the removal of fatty tissue deposits specifically in the following areas: flanks, abdomen, internal legs, trochanter, buttocks, and arms. A minimum of 5 to a maximum of 6 treatments were performed for each patient, with the device, every two weeks and with a follow‐up of 6 weeks. Circumference reduction, side effects, and patient pain were evaluated for all patients. Results A set of 42 patients were evaluated. The mean circumference reduction at 6 weeks was 2.42 ± 0.4 cm ( p  < 0.001). Treatment was well‐tolerated (pain score, 3.24 ± 1.03) by all patients. There were no adverse events and patients declared to be satisfied with the aesthetic results obtained with the treatment. Conclusion The new device emerges as a valid and safe treatment for all patients and shows a higher security profile with no side effects.