The study is a prospective, non-randomized, single arm trial that involves 20 patients. The study objective is to clinically evaluate the size of the ablation zones produced in liver tissue by BSD’s patented Synchronous Wave Alignment technology developed for MicroThermX.
Both cirrhotic and non-cirrhotic liver tissue will be evaluated in this clinical study. The study is open for patient enrollment at the University of Utah School of Medicine.
The MicroThermX utilizes patented, innovative, Synchronous Wave Alignment technology developed by BSD to provide larger and more uniform zones of ablation across all tissue types during a single procedure.
The University of Utah study will evaluate the ability of MicroThermX to create larger heating zones, using multiple antennas, than achieved by other available microwave ablation systems. Simultaneously utilizing multiple antennas gives physicians the ability to create a large, contiguous zone of necrosis with large margins. Larger, hotter heating zones may also decrease the occurrence of inadequate treatment of larger tumors
The MicroThermX is a compact, mobile system that includes a microwave generator, single-patient-use disposable antennas and a thermistor-based temperature monitoring system. The innovative design of the MicroThermX is the first of its kind that allows delivery of higher power levels using a single generator.
The US Food and Drug Administration (FDA) has granted the company a 510(k) clearance to market the MicroThermX for ablation of soft tissue. BSD has also received CE Marking for the MicroThermX system, which allows BSD to market MicroThermX in Europe.
