The study will assess the safety and performance of the AI-powered guidewire in large-vessel acute ischemic stroke patients
Sensome, a spin-off from CNRS and Ecole polytechnique, has commenced the human trial for its artificial intelligence (AI) powered stroke guidewire.
Australia-based Gold Coast University Hospital (GCUH) has recruited the first patients in Sensome CLOT OUT first-in-human study, which will assess the safety and performance of the Clotild smart guidewire system in large-vessel acute ischemic stroke patients.
The multicentre and prospective trial will be conducted at leading stroke centres across Australia, Belgium and France. Sensome intends to recruit up to 100 patients in the trial.
In a statement, GCUH interventional neuroradiology director Dr Hal Rice said: “The Clotild guidewire is the first device that promises to provide live real time information during the intervention that can help increase our chances to choose the right interventional approach from the get-go.”
Acute ischemic stroke, a major reason for long-term disability, is said to be treated by removing the clot blocking the brain blood vessel using mechanical thrombectomy devices that are guided from the wrist or groin over a wire to the blockage.
Featuring the company’s AI-powered tissue sensor, Clotild smart guidewire system allows the guidewire to deliver critical information on the clot to physicians.
In June this year, Sensome received approval from the Food and Drug Administration (FDA) for its Clotild system.
The company’s sensor technology has the potential to turn invasive medical devices into connected healthcare devices.
Its sensing technology integrates impedance-based micro-sensors with machine learning algorithms to instantly detect biological tissues.
Sensome CEO and co-founder Franz Bozsak said: “After seven years of intense R&D we are now starting a new chapter.
“We are very excited to work with an exceptional team of investigators to achieve our goal of making a difference for large-vessel acute ischemic stroke patients.”
The company is planning to reveal the data from the first cases at this year’s international LINNC Conference in Paris and interactive online stroke event SLICE Worldwide.
Sensome’s sensor technology is developed for deployment in various other medical fields, including interventional cardiology and oncology.