The objective of this clinical investigation is to assess the safety and performance of the SonoClear® System. 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 the SonoClear® System relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of high-grade glioma (HGG) and low-grade glioma (LGG) at up to 5 sites in Germany will be included. Additionally, safety data are collected at 72 hours, 30 days and 6 months post procedure.
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Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
Timeframe: Ultrasound guided brain tumor resection procedure/surgery
Surgeons Image Rating (SIR) to assess the image quality
Timeframe: Ultrasound guided brain tumor resection procedure/surgery
Adverse events up to 6 months post procedure
Timeframe: safety data are collected up to 6 months post procedure