Status:
RECRUITING
A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery
Lead Sponsor:
SonoClear AS
Conditions:
Brain Tumor Adult
Low Grade Glioma (LGG), High Grade Glioma (HGG)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 assessm...
Detailed Description
Ultrasound images will be obtained at different timepoints during the operation. First timepoint being after craniotomy (no fluids involved). Second timepoint being when some tumour is left in the bot...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Not able to give consent (e.g., severe cognitive impairment)
- History of brain radiation therapy
- Recent meningitis (within 6 months prior to screening visit)
- Other active infection (within 30 days prior to screening visit)
- Immuno-incompetent patient (e.g., failing immune system due to AIDS)
- Patients taking immune-suppressive medication
- Intended biopsy only (meaning cases not suitable for resection)
- Known hypersensitivity to egg protein
- Known hypersensitivity to soybean or peanut protein
- Known Hypersensitivity to glycerol
- Pregnant or lactating females or females who intend to become pregnant during the time of the study
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07042620
Start Date
February 1 2026
End Date
September 1 2026
Last Update
February 10 2026
Active Locations (4)
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1
Bezirkskrankenhaus Günzburg
Günzburg, Germany, 89312
2
Universitätsklinikum Gießen und Marburg GmbH Standort Marburg
Marburg, Germany, 35033
3
Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery
Tübingen, Germany, 72076
4
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany, 78052