RecruitingNot ApplicableNCT07042620

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

Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear® System Mimicking Brain Tissue.

Sponsor

SonoClear AS

Enrollment

15 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Brain Tumor Adult Low Grade Glioma (LGG), High Grade Glioma (HGG)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new fluid (contrast agent) designed to improve the clarity of ultrasound images taken during brain tumor surgery. Surgeons use intraoperative ultrasound to see brain tumors in real time, and better image quality may help them remove more of the tumor safely. The study tests this fluid in patients undergoing surgery for glioma (a type of brain tumor). **You may be eligible if...** - You are 18 or older - You are scheduled for surgery to remove a glioma (brain tumor), confirmed by MRI or tissue biopsy - Your overall health is reasonably good (Karnofsky ≥70) - Your life expectancy is more than 30 days - If you are a woman of childbearing potential, you have a negative pregnancy test **You may NOT be eligible if...** - You cannot give informed consent due to severe cognitive impairment - You have previously received radiation therapy to the brain - You had meningitis within the past 6 months - You are unable to safely receive the contrast fluid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESonoClear(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

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NCT07042620

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