Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma
brief summary
This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.
detailed description
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported \[Time Frame: Through study completion, up to 24 weeks\].
To determine the incidence and severity of device-related AEs for bevacizumab plus NaviFUS System treatment in patients with recurrent glioblastoma multiforme (rGBM), the following safety parameters will be assessed: AEs, physical examination (PE), vital signs, neurological examination (NE), Karnofsky Performance Status (KPS), Mini-Mental State Examination (MMSE), clinical laboratory tests, proteinuria, and ECG.
official title
An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma