New wearable diagnostic device being developed to detect venous thrombosis - Tampere University participates in clinical studies
ThrombUS+ brings together an interdisciplinary team of industrial, technology, regulatory, social science and clinical trial experts to develop a novel wearable diagnostic device for point-of-care, operator free, continuous monitoring in patients with high DVT risk.
The ThrombUS+ project plans a wearable ultrasound probe for continuous lower limb vascular imaging, including innovation on the tissue compression actuator required to realize compression imaging for DVT detection. The project also integrates electrical impedance plethysmography and light reflection rheography to create a robust suite of vascular assessment methods all in one autonomous wearable.
The ThrombUS+ Horizon EU Project has officially initiated the second phase of clinical studies, ThrombUS+ Clinical Study B1 to collect compression ultrasound videos using the newly developed ultrasound ThrombUS+ probe, specially designed to be integrated into a wearable for autonomous, point-of-care monitoring for deep vein thrombosis (DVT) of the lower limbs.
In addition, the project has successfully enrolled more than 1,900 patients as part of a multicenter clinical study across five hospitals in Greece, Lithuania, Italy and France. The study aims to create one of the largest open-access compression ultrasound datasets using conventional ultrasound scanners to train, validate, and test Artificial Intelligence (AI) models for the automated detection of deep vein thrombosis.
New technology aims to enhance diagnosis and monitoring
In parallel, a clinical study is underway at Tampere University to collect clinical data using the newly developed electrical impedance plethysmography device.
"The device used in the study was developed at Tampere University as part of the ThrombUS+ project, and the measurement data collected is further utilized to improve the performance of the device and for the development and training of machine learning and AI models for detecting DVT," says Sami Maja, one of the researchers involved in the project
The project paves the way towards the new era of disruptive diagnostics where artificial intelligence and ultraportable or even wearable technology promise to alleviate the burden on practitioners and transition diagnostics into continuous and autonomous point-of-care services.
"A wearable system combining multiple sensing modalities could have a significant impact on the diagnosis and monitoring of DVT in the future. If the method under development proves to be clinically reliable, it could enable early DVT detection through continuous monitoring and AI-based decision making, particularly in high-risk patients."
ThrombUS+ is supported by a substantial 9.5M€ fund from Horizon Europe Innovation Action. Partners from eight European countries are tasked with the development of an innovative wearable diagnostic device for point-of-care, operator-free, continuous monitoring of deep vein thrombosis (DVT). The project is being led by Prof. Eleni Kaldoudi of the Athena Research Center and has partners from Greece, Lithuania, France, Germany, Italy, Finland, Spain, and the UK.
Consortium
1) Athena Research Center, Greece
2) Kaunas University of Technology, Lithuania
3) Vermon SA, France
4) Fraunhofer IPMS, Germany
5) Telemed Ultrasound Medical Systems, Lithuania
6) medis Medizinische Messtechnik GmbH, Germany
7) ComfTech srl, Italy
8) Tampere University, Finland
9) Lietuvos sveikatos mokslų universitetas (LSMU), Lithuania
10) Papageorgiou General Hospital, Greece
11) Fondazione Casa Sollievo della Sofferenza, Italy
12) Hôpital Simone Veil - Groupement hospitalier Eaubonne-Montmorency, France
13) VDE, Germany
14) Medea Project, Italy
15) Phaze Clinical Research & Pharma Consulting SA., Greece
16) PredictBy, Spain
17) SciGen Technologies, SA., Greece
18) University of Derby, United Kingdom
19) University General Hospital of Alexandroupoli, Greece
For more information, including updates on the project’s progress, please visit https://thrombus.eu
