Sensome announced the publication of first-in-human results from the CLOT OUT study evaluating its Clotild smart guidewire system.
Findings published in the Journal of Neurointerventional Surgery demonstrated, for the first time, the ability of Clotild to accurately characterize clot from inside a fully occluded brain vessel. The study showed that Clotild can differentiate clot from surrounding tissue and reveal true clot boundary during mechanical thrombectomy. Additionally, the system met all primary endpoints in the study, the Paris-based company said.
Sensome designed the Clotild clot-sensing guidewire to integrate what it labels the world’s smallest electrical impedance sensor with predictive models to instantly identify clot composition and true clot position in situ. This reduces guesswork and informs treatment approaches during mechanical thrombectomy.
Clotild integrates the sensor into a standard 0.014” guidewire and provides physicians with real-time, in situ biological intelligence about the occlusion.
The company demonstrated Clotild’s feasibility with the Robotcath R-One system in March.
In the latest study, Clotild successfully differentiated between blood, clot and arterial wall. It also identified the distal end of clots and thereby characterized clot length, with no use of contrast agent. Sensome said the system showed no vessel perforation, dissection or serious adverse events.
CLOT OUT, a first-in-human, international, multi-center, single-arm study used Clotild in 41 acute ischemic stroke patients across three centers in Australia and France.
Frank Bozsak, CEO and co-founder of Sensome, said:
“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. 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.”
Dr. Andrew Cheung, coordinating investigator of CLOT OUT at Liverpool Hospital in Australia, and first author of the publication, said:
“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.”
