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

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 inclu

Trial Details

NCT ID
NCT07042620
Phase
NA
Sponsor
SonoClear AS
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • SonoClear(R) System
Locations (sample)
  • Günzburg, Germany|48.45599,10.27695
  • Marburg, Germany|50.80904,8.77069
  • Tübingen, Germany|48.52266,9.05222
  • Villingen-Schwenningen, Germany|48.06226,8.49358

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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