Sensome’s Clotild Smart Guidewire System Studied in CLOT OUT FIH Trial for Large-Vessel Acute Ischemic Stroke

September 13, 2021—Sensome announced the commencement of the company’s CLOT OUT first-in-human study evaluating the safety and performance of the Clotild smart guidewire system in large-vessel acute ischemic stroke patients.

According to the company, the Clotild system integrates Sensome’s artificial intelligence–powered tissue sensor that enables the guidewire to provide physicians with critical information on the clot characteristics. The Clotilde connected guidewire system for the treatment of ischemic stroke is the first application of Sensome’s sensing technology, which combines impedance-based microsensors with machine learning algorithms to instantly identify biologic tissues with predictive reliability. Sensome is a spin-off from CNRS—France’s Centre National de la Recherche Scientifique—and Ecole Polytechnique in Paris, France.

CLOT OUT is a multicenter, prospective trial intended to enroll up to 100 patients at leading stroke centers in Australia, Belgium, and France. Andrew Cheung, MBBS, and Dennis Cordato, MBBS, who are from the Liverpool Hospital in Liverpool, Australia, serve as a co-coordinating investigator of the study.

Dr. Cheung stated in the Sensome announcement, “Evidence has been mounting over the past few years that factors like the biological clot composition should be considered when choosing the fastest method to remove a clot. The CLOT OUT trial aims to demonstrate that using Clotild in humans is safe and can detect clot composition.”

Data from the first cases will be presented at the international LINNC conference held September 14-16 in Paris, France, and at the interactive, online SLICE Worldwide, an international multidisciplinary conference dedicated to stroke treatment held October 5-7, 2021.

The first patients in the trial were enrolled at Gold Coast University Hospital (GCUH) in Southport, Australia.

“Endovascular thrombectomy is no longer just about removing the clot,” commented Hal Rice, MBBS, Director of Interventional Neuroradiology at GCUH, in the company’s press release. “To get the best result for your patient, you need to get the clot out with complete revascularization the first time.” Dr. Rice continued, “The Clotild guidewire is the first device that promises to provide live real-time information during the intervention that can help increase our chances to choose the right interventional approach from the get-go.”