Charles Cobbs, Edward McClay, J Paul Duic, L Burt Nabors, Donna Morgan Murray, Santosh Kesari
{"title":"native Voyager®设备用于复发性胶质母细胞瘤患者的早期可行性研究:美国第一队列研究","authors":"Charles Cobbs, Edward McClay, J Paul Duic, L Burt Nabors, Donna Morgan Murray, Santosh Kesari","doi":"10.2217/cns-2018-0013","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>Evaluation of the Nativis Voyager<sup>®</sup> device in patients with recurrent glioblastoma (rGBM).</p><p><strong>Materials & methods: </strong>Voyager is a noninvasive, nonthermal, nonionizing and portable investigational device which delivers ultra-low radio frequency energy (ulRFE<sup>®</sup>) 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>These data suggest that the Voyager is safe and feasible for the treatment of rGBM.</p>","PeriodicalId":10469,"journal":{"name":"CNS Oncology","volume":"8 1","pages":"CNS30"},"PeriodicalIF":0.0000,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2217/cns-2018-0013","citationCount":"9","resultStr":"{\"title\":\"An early feasibility study of the Nativis Voyager<sup>®</sup> device in patients with recurrent glioblastoma: first cohort in US.\",\"authors\":\"Charles Cobbs, Edward McClay, J Paul Duic, L Burt Nabors, Donna Morgan Murray, Santosh Kesari\",\"doi\":\"10.2217/cns-2018-0013\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>Evaluation of the Nativis Voyager<sup>®</sup> device in patients with recurrent glioblastoma (rGBM).</p><p><strong>Materials & methods: </strong>Voyager is a noninvasive, nonthermal, nonionizing and portable investigational device which delivers ultra-low radio frequency energy (ulRFE<sup>®</sup>) 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>These data suggest that the Voyager is safe and feasible for the treatment of rGBM.</p>\",\"PeriodicalId\":10469,\"journal\":{\"name\":\"CNS Oncology\",\"volume\":\"8 1\",\"pages\":\"CNS30\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.2217/cns-2018-0013\",\"citationCount\":\"9\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CNS Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2217/cns-2018-0013\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/12/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CNS Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2217/cns-2018-0013","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/12/14 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US.
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 (ulRFE®) 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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