Safety of BBB Disruption Using NaviFUS System in Recurrent Glioblastoma Multiforme (GBM) Patients
NCT03626896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2019-06-21
Summary
This study is to evaluate the safety and find the tolerated ultrasound dose of transient opening of the blood-brain barrier (BBB) by using the NaviFUS System in recurrent GBM patients.
Conditions
- Glioblastoma Multiforme
- Brain Tumor
- Glioblastoma
- Glioma
- Neoplasms
- Neoplasms, Nerve Tissue
Interventions
- DEVICE
-
NaviFUS System
BBB Disruption by FUS in recurrent GBM Other Name: Neuronavigation-guided focus ultrasound system
Sponsors & Collaborators
-
Chang Gung Memorial Hospital
collaborator OTHER -
NaviFUS Corporation
lead INDUSTRY
Principal Investigators
-
Kuo-Chen Wei, M.D. · Chang Gung Memorial Hospital
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-17
- Primary Completion
- 2019-05-20
- Completion
- 2019-06-19
Countries
- Taiwan
Study Locations
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