PARIS — Sensome said newly published first-in-human data showed its Clotild Smart Guidewire System can accurately characterize clot composition from inside a fully occluded brain vessel during mechanical thrombectomy.
The results, from the CLOT OUT study, were published in the Journal of Neurointerventional Surgery. Sensome said the study demonstrated for the first time that the clot-sensing guidewire can differentiate clot from surrounding tissue and identify true clot boundaries during stroke treatment. The system also met all primary endpoints of the study.
Sensome, a microsensing technology company focused on intraoperative tissue analysis, said the device is designed to address imaging limitations during mechanical thrombectomy. Current imaging can show that a vessel is blocked, but it often does not reliably define clot boundaries or reveal clot composition in real time, leaving physicians to adjust their approach during the procedure.
The Clotild system integrates an electrical impedance sensor and predictive algorithms into a standard 0.014-inch guidewire. The company said the technology is intended to provide real-time biological information about the occlusion during the procedure and help physicians make more informed treatment decisions.
In the CLOT OUT study, the guidewire successfully differentiated between blood, clot and arterial wall. It also identified the distal end of clots and characterized clot length without using contrast agent. Sensome said there were no vessel perforations, dissections or serious adverse events.
The study was an international, multicenter, single-arm first-in-human trial involving 41 acute ischemic stroke patients at three centers in Australia and France.
“To our knowledge this is the first medical device able to provide in situ clot characterization with high precision,” the authors concluded.
They added, “In the future, it may be considered to complement angiography, providing periprocedural insights to guide the treatment strategy in neurovascular interventions.”
“We know that factors such as clot length and platelet content affect outcomes, but we have only had an indistinct view from outside the body and have not had a way to accurately obtain this information. With continuous impedance measurements obtained during navigation with the smart guidewire, we were able, for the first time, to obtain detailed information from inside the occlusion itself and reconstruct the compositional scan of an in situ clot in an occluded vessel in the brain. This new intelligence has the potential to improve outcomes at any center conducting mechanical thrombectomy by simply replacing a conventional guidewire with a smart one,” said Andrew Cheung, MD, coordinating investigator of the CLOT OUT study at Liverpool Hospital in Australia and first author of the publication.
Sensome CEO and co-founder Franz Bozsak said the study validates the company’s platform technology and its potential role in thrombectomy.
“We are excited that this study validates the unprecedented ability of our platform technology to lift the ‘information fog’ created by today’s imaging and reveal the true make-up and position of an occlusion. By providing physicians with accurate biological intelligence for the first time, we intend to transform thrombectomy,” Bozsak said. “Our broader vision is to combine the detailed clot and tissue information obtained from our smart wires with imaging and clinical data in one valuable database that provides AI-fueled insights to support physicians.”
