Sensome Completes First-in-Human Study for Clot-Sensing Guidewire

Sensome has announced positive results for its first-in-human clinical trial evaluating the safety and performance of its Clotild Smart Guidewire System used during mechanical thrombectomy treating ischemic stroke. 
 
Professor Aymeric Rouchaud, principal investigator of the CLOT OUT study at CHU Limoges in France, presented the results at the international LINNC Paris conference in France.
 
The clot-sensing Guidewire integrates small electrical impedance sensors with machine learning and is being developed to identify clot composition and clot length in real time to inform treatment approaches during mechanical thrombectomy. The Clotild Guidewire System has the potential to be the first device to identify clot length in fully occluded arteries in situ, as well as the first to characterize clots that remain in the body after failed removal attempts.

“Meeting all of the primary endpoints in our first-in-human study is an important milestone for our company and the first step in realizing the full potential of our novel microsensor technology across several indications,” said Franz Bozsak, CEO and co-founder of Sensome. “In this first use in stroke treatment, we showed that our technology was able to automate clot component identification with the accuracy of human experts. We look forward to further clinical study of Clotild in larger numbers of patients that will grow its capabilities to ultimately provide recommendations for a personalized treatment approach for each clot and patient.”
 
“Understanding the clot is critical to informing the approach we take to clot removal in life-saving stroke treatment, yet today’s imaging provides incomplete information. This results in 60% of thrombectomy cases requiring two or more passes to remove clot – with each pass reducing patient outcomes – and 10-20% of cases being unsuccessful in removing clot altogether,” Rouchaud told the press. “This first-in-human study showed that this smart guidewire safely navigated through the brain and successfully characterized common clot components without human analysis. This is an exciting development with the potential to give us a more complete picture of the clot that we are missing today in order to achieve better first pass success.”
 
The results showed that the technology met all primary safety and performance endpoints of the trial.1 There were no serious adverse events related to using the Clotild device, and it successfully automated the identification of red blood cells (RBCs) and platelets in close alignment with human experts. 
 
The CLOT OUT study showed that, on a blinded validation dataset, the Clotild technology’s predictive algorithms successfully identified RBCs and platelets, demonstrating automated processing of thrombus signals acquired in situ by the sensor during the thrombectomy procedure. The technology demonstrated a sensitivity of 95% [95% CI, 86%-100%] and specificity of 93% [95% CI, 90%-96%] for RBCs, and a sensitivity of 87% [95% CI, 76%-96%] and specificity of 94% [95% CI, 90%-96%] for platelets, when compared to analysis by a human expert.1
 
The study was conducted in France and Australia consisting of 41 patients with acute large-vessel ischemic stroke where the Clotild guidewire was used before any thrombectomy passed. The study was intended to further enhance Clotild’s in situ clot characterization performance. 
 
“In addition to the promise of improving our thrombectomy results, we appreciate that this technology integrated well with our current interventional workflow and didn’t require a new technique,” said Andrew Cheung, MD, co-coordinating investigator of the CLOT OUT trial at Liverpool Hospital in Australia. “The Clotild device is ingenious – by simply replacing our existing guidewire with a smart wire, we may be able to gain better information that could help us significantly improve our patients’ chances of a full recovery after stroke.”