The fluid is an opaque lipid emulsion with acoustic properties similar to brain tissue. This simple property, simulating the damping of acoustic waves in brain tissue, allows SonoClear to effectively eliminate image artifacts in resection cavities.
SonoClear was established in 2016 as a spin off from the Ultrasound and Image-Guided Therapy Centre in Trondheim.
The Trondheim area in Central Norway is considered one of the top medical ultrasound clusters in the world, with several prominent institutions and companies.
Surgeons and engineers from St. Olavs Hospital, NTNU (Norwegian University of Science and Technology) and the research foundation SINTEF has collaborated for more than 20 years to develop new techniques for intraoperative ultrasound guided surgery.
2009 – 2010:
Pre-clinical test I: subcortical injection of fluid in rats
Pre-clinical test II: injection of fluid in subarachnoid space in pigs
2013 – 2016:
Phase I clinical trial, 15 patients with glioblastoma (St. Olav’s Hospital)
2017 – 2018:
Product design and development; Quality Management System build-up, Regulatory strategy and pilot Manufacturing, according to ISO 13485 Medical Device
2019 – 2021:
Verification testing, QMS system completion, Pivotal (CE- mark) multicenter clinical trial with low-grade and high-grade glioma patients, regulatory filing
Please contact us if you wish to know more.