Sensome’s Clotild Clot-Sensing Guidewire for Ischemic Stroke Treatment Studied in CLOT OUT Trial

June 5, 2024—Sensome, a developer of microsensing technology for instant intra-operative tissue analysis, announced positive results from its first-in-human CLOT OUT clinical trial.

The trial is evaluating the safety and performance of the company’s Clotild smart guidewire system used during mechanical thrombectomy treating ischemic stroke.

Professor Aymeric Rouchaud, MD, who is principal investigator of the CLOT OUT study at CHU Limoges in Limoges, France, presented the findings at the international LINNC Paris 2024 conference held June 3-5 in Paris, France.

Sensome stated that its Clotild clot-sensing guidewire integrates a small electrical impedance sensor with machine learning. It is being developed to instantly identify clot composition and clot length in real-time to inform treatment approach during mechanical thrombectomy. The company is partnered with Asahi Intecc for manufacturing of the Clotild smart guidewire system.

According to the company, Clotild met all primary safety and performance endpoints of the trial. There were no serious adverse events related to use of the device, and it successfully automated the identification of red blood cells (RBCs) and platelets in close alignment with human experts.

As summarized in Sensome’s press release, the CLOT OUT study showed that, on a blinded validation dataset, the Clotild technology’s predictive algorithms successfully identified RBCs and platelets, thereby demonstrating automated processing of thrombus signals acquired in-situ by the sensor during the thrombectomy procedure.

The technology demonstrated sensitivity of 95% (95% CI, 86%-100%) and specificity of 93% (95% CI, 90%-96%) for RBCs; and 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.

“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,” commented Prof. Rouchaud in the Sensome press release. “This results in 60% of thrombectomy cases requiring two or more passes to remove clot—with each pass reducing patient outcomes—and 10% to 20% of cases being unsuccessful in removing clot altogether.”

Prof. Rouchand added, “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.”

Andrew Cheung, MD, Co-coordinating Investigator of the CLOT OUT trial at Liverpool Hospital in Liverpool, Australia, stated, “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. 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.”

The Clotild smart guidewire system, which has received FDA Breakthrough Device designation, is considered an investigational device and is not approved for commercial use in the United States or any other jurisdiction.