ThrombUS+ D7.2: Midterm clinical studies recruitment reports

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.
Study A 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.
This deliverable provides a comprehensive midterm report on the clinical study recruitment progress and related operational activities for the ThrombUS+ Study A. It includes updates on finalized core documents, such as the Informed Consent Form (ICF), Case Report Form (CRF), Investigator Site File (ISF), and Trial Master File (TMF), as well as summaries of the monitoring plan, tools, and reports. These components ensure effective trial management, adherence to regulatory requirements, and high data quality. The deliverable also serves as a central resource for stakeholders, offering detailed annexes for reference and documentation of the study's ongoing compliance and performance.