Sensome Shares Positive Findings for Clotild Clot-Sensing Guidewire

Sensome, a pioneer of microsensing technology, for instant intra-operative tissue analysis, revealed publication of first-in-human results from its CLOT OUT study.

The data showed, for the first time, the ability to accurately characterize clot from inside a fully occluded brain vessel. The study showed Sensome’s Clotild smart guidewire system can differentiate clot from surrounding tissue and reveal true clot boundaries during mechanical thrombectomy.

The system integrates the world’s smallest electrical impedance sensor with predictive algorithms into a standard 0.014” guidewire. The Clotild clot-sensing guidewire was engineered to provide real-time, in-situ biological intelligence about the occlusion, aiming to reduce guesswork during thrombectomy and support more informed treatment decisions.

In the study, the Clotild guidewire successfully differentiated between blood, clot, and arterial wall. It identified the distal end of clots and characterized clot length without no use of a contrast agent, and showed no vessel perforation, dissection, or serious adverse events.

CLOT-OUT is a first-in-human, international, multicenter, single-arm study of Clotild used in 41 ischemic stroke patients at three centers in Australia and France.

“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,” said Andrew Cheung, MD, coordinating investigator of the CLOT OUT study at Liverpool Hospital in Australia and first author of the publication. “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.”

“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,” added Franz Bozsak, co-founder and CEO of Sensome. “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.”se