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SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue

SonoClear AS · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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glioblastomahigh-grade-gliomalow-grade-gliomana
The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.
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