Background
Patients enrolled in the FDA approved NovoTTF-100A Pivotal (Phase III) trial, who are randomized to the treatment group (50 / 50% chance), will be treated with the NovoTTF-100A device. The NovoTTF-100A delivers low intensity alternating electric fields to the patient’s tumor site (SCIENCE).
The Device
The NovoTTF-100A is a non-invasive device, consisting of four sets of insulated electrodes attached to an electronic box. The technician places the electrodes on the outside of the scalp. The electrodes generally resemble bandages with wires attached. The electrodes connect to a portable TTField-generating box running off a battery. The device is lightweight (approximately 6 lbs) and fits neatly into a dedicated carrying case that will be provided to the patient.
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION USE ONLY.
Patient Treatment
The patient wears the device continuously for as long as their disease is stable or regressing. NovoCure (COMPANY) will provide the patients with around the clock technical support. During the treatment the patient will be able to maintain normal daily activity.