Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated May 14, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-15
notable Primary completion moved earlier: 2026-09 -> 2026-06 2026-05-15
minor Completion pushed: 2026-09 -> 2026-11 2026-05-15
Trial Details
NCT Number NCT07042620
Lead Sponsor SonoClear AS
Conditions Brain Tumor Adult, Low Grade Glioma (LGG), High Grade Glioma (HGG), Glioblastoma
Enrollment 15 participants
Start Date 2026-02-09
Primary Completion 2026-06 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-14