ThrombUS+ D3.6: Complete prototypes of US probe (10 prototypes)

This deliverable outlines the assembly and integration process carried out on the ThrombUS+ compression ultrasound device, with a focus on the integration and verification of the Ultrasound Imaging Module (USM) and the Wearable Actuator Module (WAM) to enable operator-independent monitoring for Deep Vein Thrombosis (DVT).
A total of ten complete system prototypes were finalized, each comprising an ultrasound probe, beamformer, and wearable actuator module. During prototype selection, the VERMON LA6.0/128 linear array transducer was selected as the most suitable probe. The USM performance was evaluated through inter-prototype variability testing in both B-mode and Color- Flow Doppler imaging. Results demonstrated highly consistent imaging performance across all ten prototypes. In B-mode, visual and quantitative analyses showed negligible differences. In Doppler mode, minor variations in flow detection sensitivity were observed, confirming uniform functionality across units. The WAM enables controlled tissue compression using the Electronic Actuator Controller (EAC) and a redesigned C-shell semi-rigid wearable (CSW).
In conclusion, the ThrombUS+ prototypes demonstrated equivalent, reliable, and reproducible performance, with negligible inter-unit variability. Based on these results, four systems have been allocated for manual ultrasonography in Clinical Study B1, while six fully integrated wearable systems are prepared for integration into the complete ThrombUS+ system within Work Package WP6 and for automated monitoring in Clinical Study C, supporting the project’s readiness for clinical evaluation.