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RECRUITING
NCT07042620
NA

A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery

Sponsor: SonoClear AS

View on ClinicalTrials.gov

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

DEVICE

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