Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that Gold Coast University Hospital (GCUH) in Australia enrolled the first patients in the Company’s CLOT OUT first-in-human study evaluating safety and performance of the Clotild® Smart Guidewire System in large-vessel acute ischemic stroke patients.
Acute ischemic stroke, a leading cause of long-term disability, can be treated by removing the clot blocking the brain blood vessel using mechanical thrombectomy devices, which are guided from the wrist or groin over a wire to the blockage. To improve patient prognosis, the clot needs to be removed as fast as possible. Today, without knowledge of the clot’s characteristics, the clot can only be removed on the first attempt in one out of three cases. Clotild® Smart Guidewire System integrating Sensome’s AI-powered tissue sensor enables the guidewire to provide physicians with critical information on the clot.
“Endovascular thrombectomy is no longer just about removing the clot. To get the best result for your patient, you need to get the clot out with complete revascularization the first time,” explains Dr Hal Rice, Director of Interventional Neuroradiology at GCUH, “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.”
“Evidence has been mounting over the past few years that factors like the biological clot composition should be considered when choosing the fastest method to remove a clot,” indicates Dr Andrew Cheung, co-coordinating Investigator of the study with Dr Dennis Cordato, both at the Liverpool Hospital in New South Wales, Australia, “The CLOT OUT trial aims to demonstrate that using Clotild® in humans is safe and can detect clot composition.”
“After seven years of intense R&D we are now starting a new chapter,” emphasizes Franz Bozsak, CEO and co-founder of Sensome, “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.”
CLOT OUT is a multicenter, prospective trial intended to take place in leading stroke centers across Australia, Belgium and France and aims to enroll up to 100 patients. Data from the first cases will be presented at this year’s prestigious international LINNC Conference in Paris and interactive online stroke event SLICE Worldwide.