New Study Demonstrates Sensome’s Clot-Sensing Guidewire Precisely Identifies Clot Composition in Fully Occluded Brain Vessels for the First Time
Sensome, a biotechnology innovator specializing in microsensing technology for real-time intra-operative tissue analysis, has announced the publication of groundbreaking first-in-human results from its CLOT OUT clinical study. The findings, now published in the Journal of Neurointerventional Surgery, demonstrate for the first time the ability to accurately characterize blood clots from within a fully occluded brain vessel during stroke treatment. This milestone represents a significant advancement in the field of neurointervention, particularly for physicians performing mechanical thrombectomy procedures in patients with acute ischemic stroke.
Stroke treatment is highly time-sensitive, with outcomes closely tied to how quickly blood flow can be restored to the brain. Mechanical thrombectomy, a procedure in which a clot is physically removed from a blocked vessel, has become a standard of care for certain types of stroke. However, despite technological advances, physicians often face considerable uncertainty during the procedure. Current imaging techniques can confirm the presence of a blockage but provide limited insight into the clot’s exact composition, structure, and boundaries. This lack of detailed information forces clinicians to rely on a trial-and-error approach when selecting devices and strategies, which can delay treatment and reduce the likelihood of success.
One of the key challenges in thrombectomy is achieving what is known as the “first-pass effect,” where the clot is successfully removed in a single attempt. Achieving this outcome is associated with better patient recovery and fewer complications. However, studies suggest that approximately 60% of thrombectomy procedures fail to achieve first-pass success, often due to inadequate understanding of the clot being treated. This highlights the urgent need for tools that can provide more precise, real-time information during the intervention.
Sensome’s Clotild® Smart Guidewire System is designed to address this critical gap. By integrating an ultra-miniaturized electrical impedance sensor—the smallest of its kind—with advanced predictive algorithms into a standard 0.014-inch guidewire, the system enables physicians to gather biological information directly from within the occlusion. As the guidewire navigates through the blocked vessel, it continuously measures electrical impedance, allowing it to differentiate between various tissue types and provide a detailed profile of the clot in real time.
The results from the CLOT OUT study highlight the potential of this technology to transform clinical practice. In the trial, the Clotild guidewire successfully distinguished between blood, clot, and arterial wall tissue with high precision. It was also able to identify the distal end of the clot, effectively determining clot length without the need for contrast agents—an important advantage in reducing patient exposure to additional substances during the procedure. Importantly, the study reported no cases of vessel perforation, dissection, or other serious adverse events, underscoring the safety profile of the device.
The study authors noted that, to their knowledge, this is the first medical device capable of providing such precise in situ characterization of a clot within a fully occluded vessel. They suggested that, in the future, this technology could complement traditional angiography by offering additional procedural insights that guide treatment decisions in real time. By enhancing the information available to physicians, the system has the potential to improve both the efficiency and effectiveness of neurovascular interventions.
The CLOT OUT study itself was an international, multicenter, single-arm trial involving 41 patients with acute ischemic stroke. The research was conducted across three leading medical centers in Australia and France, reflecting a collaborative effort to evaluate the technology in diverse clinical settings. As a first-in-human study, its primary objectives included assessing the safety and feasibility of the Clotild system, both of which were successfully achieved.
According to Andrew Cheung, the coordinating investigator of the study based at Liverpool Hospital in Australia, the ability to directly analyze a clot from within the vessel represents a major breakthrough. He explained that factors such as clot length and composition—particularly platelet content—are known to influence procedural outcomes, yet clinicians have historically lacked reliable methods to measure these characteristics during intervention. With the Clotild guidewire, continuous impedance measurements enable the reconstruction of a compositional map of the clot in real time, providing insights that were previously unattainable.
Dr. Cheung emphasized that this new level of biological intelligence could significantly improve outcomes in mechanical thrombectomy procedures. By simply replacing a conventional guidewire with a smart, sensing-enabled device, physicians may be able to make more informed decisions, select the most appropriate tools, and increase the likelihood of achieving successful clot removal on the first attempt.
From a broader perspective, Sensome views this innovation as part of a larger effort to overcome the limitations of current imaging technologies. Franz Bozsak, CEO and co-founder of the company, described the technology as a way to “lift the information fog” that currently surrounds thrombectomy procedures. By revealing the true composition and structure of an occlusion, the system aims to eliminate much of the uncertainty that can hinder effective treatment.
Looking ahead, Sensome envisions integrating the data generated by its smart guidewire with imaging and clinical datasets to create a comprehensive, AI-driven platform. Such a platform could provide predictive insights and decision support for physicians, further enhancing the precision and personalization of stroke treatment. By combining real-time biological data with advanced analytics, the company aims to usher in a new era of data-driven neurointervention.
The implications of this technology extend beyond stroke care. The ability to characterize tissue in situ using microsensing could have applications in a wide range of medical procedures, potentially transforming how clinicians approach diagnosis and treatment across multiple specialties. For now, however, the focus remains on improving outcomes for stroke patients, where every minute counts and better information can mean the difference between recovery and long-term disability.
In summary, the publication of the CLOT OUT study marks a pivotal moment for Sensome and the field of neurointervention. By demonstrating the feasibility and safety of real-time clot characterization within occluded brain vessels, the study lays the foundation for a new approach to mechanical thrombectomy—one that replaces guesswork with precise, actionable data. As further clinical studies build on these findings, the Clotild Smart Guidewire System could become an essential tool in the fight against stroke, offering physicians the clarity they need to deliver faster, more effective care.
ABOUT CLOTILD
The Clotild clot-sensing guidewire is based on electrical impedance spectroscopy, which measures the biophysical characteristics of fluids or tissues in 360° surrounding the sensor, analyzed by Sensome’s proprietary predictive algorithms. Sensome has miniaturized the technology down to fit in the distal part of a standard 0.014” guidewire, directly proximal to a soft, atraumatic tip. The Clotild Smart Guidewire System has been designated as a Breakthrough Device by the FDA.
The Clotild Smart Guidewire System is considered an investigational device and is not approved for commercial use in the U.S or any other jurisdiction.
ABOUT SENSOME
Sensome, a clinical-stage healthtech start-up, provides biological intelligence to physicians during minimally invasive procedures, bridging gaps left by conventional imaging today. The company has developed a patented, breakthrough microsensor technology that combines the world’s smallest impedance-based sensor with proprietary predictive algorithms to identify and characterize tissues in situ in real time. The technology has been studied in three clinical indications, including total occlusion characterization (ischemic stroke, peripheral vascular disease) and in situ tool-in-lesion confirmation (lung cancer).
The company intends to leverage its growing tissue database to deliver AI-driven insights to physicians, and eventually, to couple this data with robotics to create physical AI enabling increasingly autonomous robotic minimally invasive interventions. Sensome partners with leading medtech companies to design, manufacture and distribute smart medical devices powered by its biological intelligence, including leading guidewire manufacturer ASAHI INTECC for the Clotild Smart Guidewire System.
