A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device

The aim of this study was to compare clinical outcomes of a noninvasive selective radiofrequency (RF) eld device (BTL Vanquish METM, BTL Industries Inc., Boston MA) with its predecessor (VanquishTM, BTL Industries Inc., Boston MA). The BTL Vanquish METM system has been thoroughly redesigned for more efficient, predictable and homogenous energy delivery to the targeted tissue.

In this multi-center study, 36 subjects with BMIs under 30 were randomly assigned to be treated in Group A (BTL Vanquish METM) or Group B (VanquishTM) in order to obtain a side by side comparison of the devices' ef cacies. Each subject re- ceived 4 weekly 45-minute treatments with the device determined by their group assignments. Measurements of subject's abdominal fat were taken prior to the first treatment and again four weeks after finishing the final treatment.

The primary outcome was abdominal fat thickness reduction as measured by ultrasound one month following each subject's final treatment. Thirty four subjects completed the study. Two patients did not complete their treatments due to the reasons unrelated to the study (one from each group). Subjects in Group A treated with BTL Vanquish METM had an abdominal fat thickness reduction of 4.17 mm, or 29.46%, while subjects in Group B treated with VanquishTM had an abdominal fat thickness reduction of only 2.72 mm, or 15.21%. The 4 weekly treatments with BTL Vanquish METM in Group A produced a 53% higher reduction (4.17 mm vs 2.72 mm) of abdominal fat layer thickness than those in Group B. The standard deviation of ultrasound measurements in Groups A and B were 1.42mm and 2.21mm, respectively. Assuming a homogenous response across the entire treatment area, the volume of fat reduced was calculated by multiplying the average measured reduction in fat layer by the surface area of the treatment applicator (2100 cm2; 325.5 square inches). It was calculated that Group A patients lost an average of 0.876 liter (0.23 liquid gallon) of fat, while Group B patients lost 0.571 liter (0.15 liquid gallon) of fat.

The mean difference between the tested groups was statistically significant proving better outcomes in the Vanquish METM than its predecessor. Furthermore, the reduction in standard deviation of fat reduction measurements in Group A vs Group B is evidence that the Vanquish METM provides more consistent performance. J Drugs Dermatol. 2016;15(12):1557-1561.