Sensor system showed high specificity, sensitivity for thrombectomy in ischemic stroke

A system for mechanical thrombectomy treating ischemic stroke demonstrated a high level of sensitivity and specificity compared with human evaluation in a recent clinical trial, according to the manufacturer.

Results of the CLOT OUT study showed that the Clotild Smart Guidewire System met all primary safety and performance endpoints, without serious adverse events related to use of the device, Sensome reported in a press release.

The single-arm, prospective, multicenter study was conducted in France and Australia and included 41 individuals with acute large-vessel ischemic stroke where the Clotild guidewire was used prior to thrombectomy.

The system, which has been granted breakthrough device designation by the FDA, also successfully automated identification of red blood cells (RBCs) and platelets in close alignment with human experts tasked with evaluating the same.

The guidewire integrates an electrical impedance sensor with machine learning and is being developed to identify clot composition and length accurately and rapidly in real time to guide treatment approach during mechanical thrombectomy, according to the release.

The Clotild system demonstrated sensitivity of 95% and specificity of 93% for RBCs, along with a sensitivity of 87% and specificity of 94% for platelets, compared with analysis by a human expert, according to data cited in the release.

“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,” Sensome founder and CEO Franz Bozsak said in the release. “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.”