
The NovoTTF is a portable, investigational device for cancer treatment using TTFields – Tumor Treating Fields (SCIENCE). The device is intended for continuous home use by patients (TREATMENT) with a recurrent or progressive GBM tumor (ELIGIBILITY). Two of ten recurrent GBM patients from the pilot clinical study are feeling well and their tumors have not progressed, more than two years after initiating treatment. One of these two patients has no tumor visible by MRI (CLINICAL EXPERIENCE).
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION USE ONLY.
The study is a Pivotal (Phase III), randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A (TRIAL). The trial’s expected total enrollment is 236 patients. The trial is now enrolling patients in multiple centers in the US and Europe (CENTERS).
