Periodic Reporting for period 1 - ThrombUS (ThrombUS+: Wearable Continuous Point-of-Care Monitoring, Risk Estimation and Prevention for Deep Vein Thrombosis)
Reporting period: 2024-01-01 to 2025-06-30
Deep vein thrombosis (DVT) is the formation of a blood clot within the deep veins, most commonly those of the lower limbs, causing obstruction of blood flow. In 50% of people with DVT, the clot eventually breaks off and travels to the lung to cause pulmonary embolism. Clinical assessment of DVT is notoriously unreliable because up to 2/3 of DVT episodes are clinically silent and patients are symptom free even when pulmonary embolism has developed. Early diagnosis of DVT is crucial and despite the progress made in ultrasound imaging and plethysmography techniques, there is a need for new methods to enable continuous monitoring DVT diagnosis at the point of care.
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 device will combine autonomous, AI driven DVT detection based on a novel wearable ultrasound hardware, impedance plethysmography and light reflection rheography for immediate detection of blood clot formation in the lower limb. Activity and other physiological measurements will be used to provide a continuous assessment of DVT risk and support DVT prevention via serious gaming. The aggregated data will drive an intelligence decision support unit that will provide accurate monitoring and alerts. Extended reality will be used to guide experts to design exercises and patients to use the device optimally.
ThrombUS+ is intended for use by postoperative patients in the ward, during long surgical operations, cancer patients or otherwise bedridden patients at home or in care units, and women during pregnancy and postpartum. ThrombUS+ will use big data sets for AI training collected in the project via 3 large scale clinical studies and will validate the outcome in the clinical setting via 1 early feasibility study and 1 multi-center clinical trial.
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 device will combine autonomous, AI driven DVT detection based on a novel wearable ultrasound hardware, impedance plethysmography and light reflection rheography for immediate detection of blood clot formation in the lower limb. Activity and other physiological measurements will be used to provide a continuous assessment of DVT risk and support DVT prevention via serious gaming. The aggregated data will drive an intelligence decision support unit that will provide accurate monitoring and alerts. Extended reality will be used to guide experts to design exercises and patients to use the device optimally.
ThrombUS+ is intended for use by postoperative patients in the ward, during long surgical operations, cancer patients or otherwise bedridden patients at home or in care units, and women during pregnancy and postpartum. ThrombUS+ will use big data sets for AI training collected in the project via 3 large scale clinical studies and will validate the outcome in the clinical setting via 1 early feasibility study and 1 multi-center clinical trial.
Project initiation, including setting up all operational infrastructure, tools and procedures (WP1).
Definition of needs, requirements, and architecture (WP2).
Development and initiation of testing for all wearable device hardware (and middleware) components (WP3 and WP4).
Initiation of software development (WP5).
Definition of integrated system specifications and testing methodology and plan (WP6).
Setting up of the infrastructure, tools and methodology for Clinical Studies; initiation of Clinical Study A and Clinical Studies B (WP7).
Definition of dissemination and communication plan, establishment of related tools and infrastructure and engagement in respective activities (WP8).
Establishment of regulatory monitoring, templates and training; establishment of an exploitation plan and initiation of respective activities (WP9).
Recruitment of an External Ethics Advisor and respective engagement for project ethics monitoring – as requested by the Grant Managing Authority at Grant Agreement (WP10).
Definition of needs, requirements, and architecture (WP2).
Development and initiation of testing for all wearable device hardware (and middleware) components (WP3 and WP4).
Initiation of software development (WP5).
Definition of integrated system specifications and testing methodology and plan (WP6).
Setting up of the infrastructure, tools and methodology for Clinical Studies; initiation of Clinical Study A and Clinical Studies B (WP7).
Definition of dissemination and communication plan, establishment of related tools and infrastructure and engagement in respective activities (WP8).
Establishment of regulatory monitoring, templates and training; establishment of an exploitation plan and initiation of respective activities (WP9).
Recruitment of an External Ethics Advisor and respective engagement for project ethics monitoring – as requested by the Grant Managing Authority at Grant Agreement (WP10).
Development and initiation of testing for all wearable device hardware (and middleware) components (WP3 and WP4).
Definition of integrated system specifications and testing methodology and plan (WP6).
Definition of integrated system specifications and testing methodology and plan (WP6).