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An early feasibility study of the Nativis Voyager ® device in patients with recurrent glioblastoma: first cohort in US

Authors
  • Cobbs, Charles1, 1
  • McClay, Edward2, 2
  • Duic, J Paul3, 3
  • Nabors, L Burt4, 4
  • Morgan Murray, Donna5, 5
  • Kesari, Santosh6, 6
  • 1 Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment, Swedish Medical Center, Seattle, WA 98122, USA
  • 2 & Excellence (cCARE), San Marcos, CA 92024, USA
  • 3 Department of Neuro-oncology, New York University, Winthrop, Mineola, NY 11501, USA
  • 4 Division of Neuro-oncology, University of Alabama, Birmingham, AL 35294, USA
  • 5 Nativis, Inc., Seattle, WA 98109, USA
  • 6 & Pacific Neuroscience Institute, Santa Monica, CA 90404, USA
Type
Published Article
Journal
CNS Oncology
Publisher
Future Medicine
Publication Date
Dec 14, 2018
Volume
8
Issue
1
Identifiers
DOI: 10.2217/cns-2018-0013
PMID: 30547676
PMCID: PMC6499016
Source
PubMed Central
Keywords
License
Green

Abstract

Aim: Evaluation of the Nativis Voyager® device in patients with recurrent glioblastoma (rGBM). Materials & methods: Voyager is a noninvasive, nonthermal, nonionizing and portable investigational device which delivers ultra-low radio frequency energy ( ul RFE®) that uses a magnetic field to penetrate tissues to alter specific biologic functions within cells. Patients with rGBM were treated with Voyager alone (V) or Voyager in combination with standard of care (V + SoC). Safety and clinical utility were assessed every 2–4 months. Results: Data from the first 11 patients treated are reported here. Median progression-free survival was 10 weeks in the V arm and 16 weeks in the V + SoC arm. Median overall survival was 16 months in V arm and 11 months in the V + SoC arm. No serious adverse events associated with the device were reported. Conclusion: These data suggest that the Voyager is safe and feasible for the treatment of rGBM.

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