Characterization of the YDME FEP‐BY02 tumor therapy system

Abstract

The YDME FEP‐BY02 is an extracorporeal tumor therapy device that has been in clinical use in China for several years. In the USA, this device is currently under investigation for the treatment of pancreatic cancer. Prior to being submitted for an application for an Investigation Device Exemption (IDE) with the FDA, the device will be required to undergo a thorough characterization of all systems involved in patient treatment. The purpose of this research is to characterize the FEP‐BY02 and obtain data for an IDE application to the FDA for the treatment of pancreatic cancer using the FEP‐BY02. A series of acoustical characterization, in vitro, and ex vivo tests are being conducted to validate the company’s preclinical and clinical experience in China. Comparisons between three methods (radiation force balance, fiber‐optic hydrophone, and scattering hydrophone) for measuring/determining focal intensities will be used to assess the validity of the measurement techniques and evaluate acoustic output over the functional input range of the FEP‐BY02. Transparent gels impregnated with thermally sensitive markers will be used to visualize lesion formation and evaluate lesion characteristics with respect to input parameters. Thermocouples implanted in tissue mimicking thermal gels and ex vivo tissue will be use to evaluate the thermal response with respect to input parameters. Preliminary data indicate that the therapeutic ultrasound treatment system forms consistent lesions at the desired target.