Sensome has begun human trials for its artificial intelligence (AI)-powered stroke guidewire at the Gold Coast University Hospital (GCUH).
The trial will evaluate the safety and efficacy of the Sensome’s Clotild Smart Guidewire system in acute ischemic stroke patients.
CLOT OUT is Sesome’s first-in-human, multicenter trial earmarked for leading stroke centers across Australia, Belgium, and France. The GCUH trial adds to this initiative.
Replacing invasive medical procedures, Sensome’s Clotild Smart Guidewire system pairs impedance-based tissue sensors with machine learning algorithms to provide physicians with valuable insights into the clot.
The AI-powered system recently gained FDA approval to aid in treating or diagnosing life-threatening and irreversibly debilitating diseases and conditions.
“Endovascular thrombectomy is no longer just about removing the clot. To get the best result for your patient, you need to get the clot out with complete revascularization the first time,” explains Dr. Hal Rice, director of interventional neuroradiology at GCUH.
Rice added, “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.”
According to reports, Sensome aims to enroll up to 100 patients in its CLOT OUT study. Data from preliminary cases will be presented at this year's LINNC conference in Paris and at SLICE Worldwide, an online interactive stroke event.
“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,” stated Dr. Andrew Cheung, co-coordinating investigator of the study at Liverpool Hospital.
