WP7 aims to deploy a series of clinical studies, including three cohort studies for data collection, an early feasibility study, and a prospective, double-blinded, pilot study of the ThrombUS+ system. Deliverable 7.1 includes the clinical studies initiation package for Study A, ensuring that requirements ethical approval is met, including informed consent and data protection aspects.
This study is a multi-center cohort study that aims to collect and create a labelled ultrasound data set containing ultrasound images series of patients that undergo routine ultrasound scans because of suspected deep vein thrombosis. The data will be used to train the AI model for automated detection of deep vein thrombosis on conventional ultrasound scans and also will be made available through the EOSC for research purposes.