SonoClear® Acoustic coupling fluid for intracavitary ultrasound imaging.

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 is:

  • Administered into the resection cavity before image acquisition
  • Easily removed from the resection cavity using suction and flushing

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.

Image with visual parallax effect

Timeline for the SonoClear adventure:

2009 – 2010:
Laboratory tests

2011:
Pre-clinical test I: subcortical injection of fluid in rats

2012:
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.