NCT07042620Active, not recruiting
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.
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 9 Feb 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- SonoClear AS
- Diseases
- Glioblastoma
- NCT number
- NCT07042620
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 9 Feb 2026 to the primary completion date, Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent meningitis (within 6 months prior to screening visit)
- Other active infection (within 30 days prior to screening visit)
- Patients taking immune-suppressive medication
- Intended biopsy only (meaning cases not suitable for resection)
Other illness
- Not able to give consent (e.g., severe cognitive impairment)
- History of brain radiation therapy
- Known hypersensitivity to egg protein
- Known hypersensitivity to soybean or peanut protein
- Known Hypersensitivity to glycerol
Other
- Immuno-incompetent patient (e.g., failing immune system due to AIDS)
- Pregnant or lactating females or females who intend to become pregnant during the time of the study
Who the study is looking for
- A diffuse malignant glial tumour (high grade (grade III and IV) or low grade (grade I-II)) is suspected from the diagnostic MRI scan
- Pre- or peri-procedural confirmed histopathology of glioma
- ≥18 years of age
- Karnofsky performance status ≥ 70
- Life expectancy of more than 30 days at the time of procedure
- Negative pregnancy test for female subjects of childbearing potential
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bezirkskrankenhaus Günzburg Coordinator of this site? Confirm its status | Günzburg | Germany | Unknown status |
| Universitätsklinikum Gießen und Marburg GmbH Standort Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.