This is a feasibility study of the Nativis Voyager System in patients with recurrent glioblastoma multiforme. In this feasibility phase of the study, the first goal is to establish that the Nativis Voyager System, an investigational medical device, is safe for use in humans who have been diagnosed with re-current GBM. We will also observe the Nativis Voyager System as a potential treatment against re-current GBM and its effectiveness in slowing, shrinking or stopping the growth of recurrent GBM tumors. The effect of the electromagnetic field generated by the Voyager device has been tested in pre-clinical animal research models. Results from these preclinical studies indicate that treatment with the Nativis Voyager System may disrupt cancer cell division, thereby slowing tumor progression. Further, pre-clinical safety studies showed no safety concerns resulting from use of the Voyager device in healthy animals.
Investigational Device Description:
- A non-invasive, non-thermal radio frequency energy (RFE) medical device
- Uses low-level radio frequency energy (RFE) to disrupt cancer cell division
- Application does NOT require head to be shaved
- Portable and lightweight. Weight = 6 oz.
- Nativis Voyager System consists of two Voyager controllers, one Voyager headband coil, and one power adapter
- Battery powered—up to 12 hours battery life per Voyager controller, per complete charge
- Treatment period: 24 hours per day / 7 days a week (or as directed by your doctor). Device may be removed for brief periods to allow for personal care
Treatment will be given in multiple cycles. Each cycle consists of 28 days. Blood test results and MRI scan will measure how well an individual is tolerating the treatment and if the tumor is growing.
If you, your family member or loved one is interested in learning more about participating in this study, please contact the Study Coordinator at 520-320-2157.