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A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery
Sponsor: SonoClear AS
Summary
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.
Official title: Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear® System Mimicking Brain Tissue.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-02
Completion Date
2026-09
Last Updated
2026-02-10
Healthy Volunteers
No
Interventions
SonoClear(R) System
The SonoClear(R) System is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings
Locations (4)
Bezirkskrankenhaus Günzburg
Günzburg, Germany
Universitätsklinikum Gießen und Marburg GmbH Standort Marburg
Marburg, Germany
Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery
Tübingen, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany