The trial is intended to assess the Clotild sensor's capacity to identify different features of blood artery blockages in PAD individuals and assess difference between fresh clots and organised old clots
Sensome starts Clotild Smart Guidewire trial in PAD treatment. (Credit: valelopardo from Pixabay)
Sensome, a start-up engaged in developing sensor technology, has enrolled the first patient in the SEPARATE feasibility clinical study of its Clotild Smart Guidewire in peripheral artery disease (PAD).
The Clotild system is Sensome’s flagship connected neurovascular guidewire designed to offer blood clot characterisation during the endovascular management of acute ischemic stroke.
The tissue microsensor technology received the breakthrough medical device status for its use in brain arteries by the US Food and Drug Administration (FDA) in 2021.
Sensome CEO and co-founder Franz Bozsak said: “After successfully applying our technology to the treatment of ischemic stroke patients, we are excited about the opportunity to build on this work to potentially help millions of patients around the world whose lives have been impacted by PAD.”
The SEPARATE trial is intended to assess the Clotild sensor’s capacity to identify different features of blood artery blockages in individuals with PAD.
Additionally, the study will focus on the evaluation of the Clotild sensor’s capacity to differentiate between soft and friable fresh clots and organised old clots.
Sensome said that this information will help doctors to choose the best endovascular therapeutic strategy to reduce problems, prevent embolisation, and improve treatment outcomes over the long run.
The first five patients for the SEPARATE trial have been registered at the AZ Sint-Blasius Hospital in Dendermonde, Belgium. The preliminary results are expected in midway through 2024.
SEPARATE principal investigator Koen Deloose said: “Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients.
“Sensome’s tissue microsensor technology could become a novel tool to characterise the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”
Sensome, which is a spin-off from CNRS and Ecole polytechnique, is working on sensor technology that turns invasive medical devices into connected healthcare devices.
The company also has plans to integrate the technology into minimally invasive medical devices for use in peripheral vascular disease and oncology treatments.