A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
NCT02296580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2023-02-02
Summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.
Conditions
Interventions
- DEVICE
-
Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Sponsors & Collaborators
-
Nativis, Inc.
lead INDUSTRY
Principal Investigators
-
Donna Morgan Murray, PhD · Nativis, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2021-09-30
- Completion
- 2021-09-30
- FDA Device
- Yes
Countries
- United States
- Australia
Study Locations
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