ThrombUS+ Project Presentation - June 2024
- 1. Project Overview E. Kaldoudi |ATHENA RC | Greece Horizon Europe Health Cluster Networking Meeting 26 June 2024 Co-funded by the European Union
- 2. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 Wearable Continuous Point-of-Care Monitoring, Risk Estimation and Prevention for Deep Vein Thrombosis Project type: IA (Innovation Action) Project Budget: 9,565,763.75 € EU funding: 8,141,251.25 € Duration: 42 months Start: 1 January 2024 End: 30 June 2027 Invited: 04 August 2023 Signed: 08 December 2023 Call Identifier: HORIZON-HLTH-2023-TOOL-05-05 Call title: Harnessing the potential of real-time data analysis and secure Point-of-Care computing for the benefit of person-centred health and care delivery Program: Horizon Europe, 4. Health, 2023-2024 Destination: 5. Unlocking the full potential of new tools, technologies and digital solutions for a healthy society Proposal submitted: 13 April 2023 2
- 3. Co-funded by the European Union Greece Lithuania Germany Italy France Finland Spain USA Horizon Europe Health Cluster Networking Meeting | 26 June 2024 3
- 5. Co-funded by the European Union Deep Vein Thrombosis (DVT) is the clotting of blood in a deep vein of the pelvis or an extremity (usually calf or thigh) https://www.usaveinclinics.com/vein-disease/deep-vein-thrombosis-dvt/ June 2024 https://www.cdc.gov/blood-clots/data-research/facts- stats/index.html#:~:text=The%20precise%20number%20of%20people,die%20of%20VTE%20each%20year. June 2024 a clot is mainly composed of fibrin and red blood cells and may contain platelets, leukocytes and other compounds a clot usually forms around the valves in the deep veins of the leg a clot forms in a matter of seconds or minutes depending on the individual when present, the clot disturbs the flow of blood and results in pain and swelling the clot might be pushed via the heart to the lungs where it can block an artery, what is know as pulmonary embolism, an acute, life-threatening event Horizon Europe Health Cluster Networking Meeting | 26 June 2024 5
- 6. Co-funded by the European Union Deep Vein Thrombosis (DVT) is a major preventable cause of morbidity and mortality worldwide ▪ 3rd most frequent vascular diagnosis after heart attack and stroke, ▪ affects more than 1,000,000 Americans per year affects more than 700,000 Europeans per year ▪ 1/2 of people with DVT experience a sudden pulmonary embolism ▪ about 25% of those who have a pulmonary embolism die from it ▪ 1/3 to 1/2 of people who have a DVT episode will have long-term complications caused by the damage the clot does to the valves in the vein ▪ annual health expenditure related to DVT is €8.5 billion in EU Olaf M et al. Deep Venous Thrombosis. Emerg Med Clin North Am. 2017 doi: 10.1016/j.emc.2017.06.003 Cohen AT et al. Thromb Haemost. 2007 Oct;98(4):756-64 Barco S et al.Thromb Haemost. 2016 Apr;115(4):800-8. doi: 10.1160/TH15- 08-0670 Horizon Europe Health Cluster Networking Meeting | 26 June 2024 6
- 7. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 clinical conditions most closely associated with DVT surgery or trauma malignancy prolonged immobility pregnancy congestive heart failure varicose veins obesity advancing age history of DVT of all DVT episodes 50% no obvious cause 20% cancer related 20% after surgery 7
- 8. Co-funded by the European Union graduated compression stockings Horizon Europe Health Cluster Networking Meeting | 26 June 2024 Sachdeva A, Dalton M, Lees T. Graduated compression stockings for prevention of deep vein thrombosis. Cochrane Database Syst Rev. 2018 Nov 3;11(11):CD001484. https://doi.org/10.1002/14651858.CD001484.pub4 Yang SD, Ning SH, Zhang LH, Zhang YZ, Ding WY, Yang DL. The effect of lower limb rehabilitation gymnastics on postoperative rehabilitation in elderly patients with femoral shaft fracture: A retrospective case-control study. Medicine (Baltimore). 2016 Aug;95(33):e4548. https://doi.org/10.1097/MD.0000000000004548 . rehabilitation gymnastics prevention of deep vein thrombosis employs anti-thrombotic medication and … 8
- 9. Co-funded by the European Union currently, ultrasonography is the method of choice for DVT diagnosis ▪ direct visualization of the thrombus ▪ Doppler to assess venous flow ▪ compression ultrasound while compressing with the US probe till the artery starts to compress, when normal, the vein fully collapses when DVT is present, vein does NOT collapse artery vein compression US Horizon Europe Health Cluster Networking Meeting | 26 June 2024 9
- 10. Co-funded by the European Union other modalities for DVT diagnosis Light Reflection Rheography measures blood volume changes in peripheral veins via reflection of light Electrical Impedance Plethysmography measures blood volume changes in peripheral veins via electrical impedance changes Credits: S. Balling, medis. Horizon Europe Health Cluster Networking Meeting | 26 June 2024 10
- 11. Co-funded by the European Union prompt diagnosis of DVT is crucial! patients are referred for an ultrasound when they present DVT-related clinical symptoms however,… up to 2/3 of DVT episodes are clinically silent and patients are symptom free pulmonary embolism events are acute, and about 25% of these result in death immediately or in a few hours, before a treatment can be applied Horizon Europe Health Cluster Networking Meeting | 26 June 2024 11
- 12. Co-funded by the European Union wearable ultrasound for DVT continuous monitoring coupled with impedance plethysmography light reflection rheography activity sensors (patient and doctor empowerment) other info (assessment of DVT risk) with AI support for autonomous monitoring, DVT risk assessment and DVT early detection image generated by MS Designer https://designer.microsoft.com/image-creator prompt: “a patient lying in a bed with subtle multiple sensors on the leg embedded in a legging with a screen in the background displaying leg movements” Horizon Europe Health Cluster Networking Meeting | 26 June 2024 12
- 13. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 B A B 2 types of bulk technology US transducers by VERMON MEMS technology US transducer by FRAUNHOFER Beamforming by TELEMED smart textile wearable by ComfTech electrical impedance plethysmography by TAU light reflection rheography by MEDIS activity sensor network by KTU pressure micropump by KTU AI based ultrasound DVT detection by EchoNous AI based DVT detection based on EIP and LRR by TAU and MEDIS DVT risk detection, activity based serious game and extended reality by ATHENA central intelligence and app by ATHENA WP3 WP4 WP5 WP3 WP6 13
- 14. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 Clinical Studies A Conventional ultrasound image set collection to create a training data set Participants >3000 B1 Training data set collection using the prototype wearable ultrasound to fine tune the AI model Participants >500 B2 Physiological signals, lower limb activity and plethysmography measurements via the ThrombUS+ prototype wearable sensor components from healthy volunteers Participants >60 C1 Early feasibility study of the ThrombUS+ integrated prototype in patients in the postoperative ward Participants 25-50 C2 Prospective, double-blinded, pilot study evaluating artificial intelligence driven automatic detection of deep vein thrombosis by the ThrombUS+ device compared to standard ultrasound imaging in patients suspected for deep vein thrombosis Participants: 50-100 14
- 15. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 Hospital Name Total TAU LSMU GNP CSS- IRCCS HSV Country 5 countries Finland Lithuania Greece Italy France Number of beds 5,703 1,000 2,232 745 750 976 Hospitalizations per year 335,372 82,897 83,192 94,205 45,000 30,078 Out-patients per year 3,171,401 1,162,227 1,228,783 244,227 300,000 236,164 Patients scanned for suspected DVT per year 11,189 3,500 4,000 939 2,400 350 Positive scans for DVT per year 2,255 700 800 188 500 67 Surgical operations per year 136,252 40,896 66,254 10,669 8,000 10,433 Orthopaedics operations per year 21,232 13,000 4,945 1,137 600 1,550 *based on data for year 2022 15
- 16. Co-funded by the European Union patient centric design • clinical survey amongst experts to identify major patient categories in risk of DVT and in need of continuousaaa monitoring • expert structured interviews to identify patient practical needs, opportunities and barriers for continuous monitoring • patient focus groups (planned) 7 major reference use cases Credits: Lucas J. Segal and Federico Puppo, PBY ThrombUS+ Reference Use Cases after surgery perinatal care cancer obesity prolonged immobility history of thrombosis genetic disorders based on literature, of all DVT episodes 50% no obvious cause 20% cancer related 20% after surgery Horizon Europe Health Cluster Networking Meeting | 26 June 2024 16
- 17. Co-funded by the European Union data driven approach Table 1. Hospitals participating in the ThrombUS+ Clinical Study A. Hospital TAU LSMU GNP CSS-IRCCS HSV Total Country Finland Lithuania Greece Italy France 5 countries Number of beds 1,000 2,232 745 750 976 5,703 Hospitalizations per year 82,897 83,192 94,205 45,000 30,078 335,372 Out-patients per year 1,162,227 1,228,783 244,227 300,000 236,164 3,171,401 Patients scanned for suspected DVT per year 3,500 4,000 939 2,400 350 11,189 Table 1. Collective numerical data for the ThrombUS_A study. Total number of patients referred for an ultrasound scan for suspected DVT per year 11,189 Positive DVT scans per year 2,547 Positive DVT scans as a percentage of referred and scanned patients per year 22% Duration of the study (in months) 12 Estimated patients available for recruitment 11,000 Expected patients to recruit 3,000 Expected patients to recruit as a percentage for available for recruitment 27% Expected positive scans in the recruited population (20%) 660 conventional ultrasound image set collection to create a training data set Participants >3000 the annonated data set will be available to the public! Drougka I, Clinical studies initiation package - Study A, Deliverable 7.1, ThrombUS+ Horizon Europe Innovation Action, EC Grant Agreement No. 101137227, 31 May 2024, https://doi.org/10.5281/zenodo.11371924 Table 1. A summary of milestones regarding the ThrombUS+ Clinical Study A Milestone Planned date IRB/IEC approval June 2024 Start of data collection July 2024 Midterm recruitment report December 2024 End of data collection June 2025 Final report of study results July 2025 Horizon Europe Health Cluster Networking Meeting | 26 June 2024 17
- 18. Co-funded by the European Union compliance by design research based on a regulatory compliance monitoring plan creation of regulatory templates for the technical documentation preparation of draft documents from templates distribution of draft documents to project partners for feedback review of feedback and incorporation into draft documents knowledge transfer on specific regulatory topics Credits: Thorsten Prinz, VDE Horizon Europe Health Cluster Networking Meeting | 26 June 2024 18
- 19. Co-funded by the European Union open science Standards • DICOM Digital Imaging and Communication in Medicine • GDF Geographic Data Files • ICD International Classification of Diseases • SNOMED-CT Systemized Nomenclature of Medicine – Clinical Terms https://thrombus.eu/ https://zenodo.org/communities/thrombus/ Horizon Europe Health Cluster Networking Meeting | 26 June 2024 19
- 20. Co-funded by the European Union work package breakdown WP 1. Management WP 2. Requirements and product co-design WP 3. Ultrasound sensing WP 4. Plethysmography, activity sensors and wearable WP 5. Decision support and action intelligence WP 6. Integration and validation WP 7. Clinical studies WP 8. Dissemination & Communication WP 9. Exploitation, and Commercialization Horizon Europe Health Cluster Networking Meeting | 26 June 2024 20
- 21. WP10. Exploitation & Commercialization Study A – Conventional data collection Τ7.2 Automated US DVT detection Τ5.1 Clinical studies initiation Τ7.1 ThrombUS+ specs Τ6.1 Hardware integration Τ6.3 Software integration intelligence and app Τ6.4 Testing methodology and plans Τ6.2 Patient-centric cases and requirements definition Τ2.1 Regulatory framework, security, safety and ethics Τ2.2 WP1. Management WP8. Dissemination & Communication WP9. Exploitation & Commercialization Testing, signal quality and performance enhancements Τ4.5 Manufacturing of wearable prototypes Τ4.6 Wearable development and integration with sensors Τ4.4 Testing, image quality and performance enhancements Τ3.5 Manufacturing of US prototypes Τ3.6 Transducer/cuff control and image formation Τ3.4 Studies B – Data collection by prototype components Τ7.3 Studies C – Clinical trials Τ7.4 Hardware and software integration & communications Τ6.5 Posting of clinical trial results Τ7.5 Technical and functional requirements Τ2.4 Co-creation of wearable strap and sock design Τ2.3 Light reflection rheography sensors development Τ4.2 Lower limb activity sensor network development Τ4.3 Impedance sensors development Τ4.1 Precise tissue compression actuator Τ3.3 Ultrasound transducer array Bulk technology Τ3.1 Ultrasound transducer array MEMS technology Τ3.2 DVT risk estimation Τ5.3 Automated plethysmography DVT detection Τ5.2 Serious game for DVT prevention Τ5.5 Extended reality for guidance Τ5.4 Horizon Europe Health Cluster Networking Meeting | 26 June 2024 21
- 22. Co-funded by the European Union Horizon Europe Health Cluster Networking Meeting | 26 June 2024 # No Lead Type Dissem Month Date 1 D8.1 SciGen DEC PU 1 Jan 2024 2 D1.1 ATHENA DEC SEN 1 Jan 2024 3 D10.1 ATHENA ETHICS SEN 1 Jan 2024 4 D1.2 ATHENA R SEN 3 Mar 2024 5 D1.3 MEDEA R SEN 3 Mar 2024 6 D8.2 SciGen R PU 3 Mar 2024 7 D9.1 VDE R PU 3 Mar 2024 8 D1.4 ATHENA DMP PU 4 Apr 2024 9 D7.1 PHAZE R PU 5 May 2024 10 D2.1 PBY R PU 6 Jun 2024 11 D2.2 VDE R PU 8 Aug 2024 12 D2.3 KTU R PU 10 Oct 2024 13 D2.4 ComfTech R SEN 12 Dec 2024 14 D3.1 VERMON DEM SEN 12 Dec 2024 15 D3.2 FRAUNHOFER DEM SEN 12 Dec 2024 16 D3.3 KTU DEM SEN 12 Dec 2024 17 D4.1 TAU DEM SEN 12 Dec 2024 18 D4.2 MEDIS DEM SEN 12 Dec 2024 19 D4.3 KTU DEM SEN 12 Dec 2024 20 D7.2 PHAZE R PU 12 Dec 2024 21 D7.3 PHAZE R PU 13 Jan 2025 22 D6.1 KTU R PU 14 Feb 2025 23 D3.4 TELEMED DEM SEN 15 Mar 2025 24 D7.4 PHAZE R PU 15 Mar 2025 25 D4.4 ComfTech DEM SEN 16 Apr 2025 26 D6.2 KTU R PU 18 Jun 2025 27 D3.5 KTU R PU 19 Jul 2025 28 D4.5 KTU R PU 19 Jul 2025 # No Lead Type Dissem Month Date 29 D7.5 PHAZE R PU 20 Aug 2025 30 D3.6 TELEMED DEM SEN 21 Sep 2025 31 D4.6 ComfTech DEM SEN 21 Sep 2025 32 D1.5 ATHENA DMP PU 24 Dec 2025 33 D7.6 PHAZE R PU 24 Dec 2024 34 D6.3 KTU DEM SEN 26 Feb 2026 35 D8.3 ATHENA DATA PU 26 Feb 2026 36 D5.1 EchoNous DEM SEN 28 Apr 2026 37 D5.2 TAU DEM SEN 28 Apr 2026 38 D5.3 ATHENA DEM SEN 28 Apr 2026 39 D5.4 ATHENA DEM SEN 28 Apr 2026 40 D5.5 ATHENA DEM SEN 28 Apr 2026 41 D6.4 ATHENA DEM SEN 28 Apr 2026 42 D7.7 PHAZE R PU 29 May 2026 43 D6.5 KTU DEM SEN 32 Aug 2026 44 D7.8 PHAZE R PU 36 Dec 2026 45 D1.6 ATHENA R SEN 42 Jun 2027 46 D1.7 MEDEA R SEN 42 Jun 2027 47 D7.9 PHAZE R PU 42 Jun 2027 48 D8.4 SciGen R PU 42 Jun 2027 49 D8.5 SciGen R PU 42 Jun 2027 50 D9.2 VDE R PU 42 Jun 2027 51 D9.3 PBY R PU 42 Jun 2027 52 D9.4 MEDEA R SEN 42 Jun 2027 53 D10.5 ATHENA ETHICS SEN 42 Jun 2027 54 D10.2 ATHENA ETHICS SEN 12 Dec 2024 55 D10.3 ATHENA ETHICS SEN 24 Dec 2025 56 D10.4 ATHENA ETHICS SEN 36 Dec 2026 52 +4 deliverables 22
- 23. Co-funded by the European Union project progress • 1st milestone reached • 9 deliverables submitted on time Horizon Europe Health Cluster Networking Meeting | 26 June 2024 23
- 24. Project Meeting 02 |Kaunas, Lithuania | 14-15 May 2024 Seal of Excellence by France the project scored the maximum of 4/4 in all 10 evaluation criteria
- 25. Co-funded by the European Union submitted public deliverables or publishable summaries can be viewed in the project website and in the project’s community in Zenodo Horizon Europe Health Cluster Networking Meeting | 26 June 2024 https://thrombus.eu/ 25
- 26. Alexandroupoli, Jan 2024 Kaunas, May 2024 Kaunas, May 2024 Kaunas, May 2024 Kaunas, May 2024 Kaunas, May 2024
- 27. Coordinator: Prof. Eleni Kaldoudi, Coordinator kaldoudi@athenarc.gr Project Manager: Dr. Stelios Didaskalou stelios.didaskalou@athenarc.gr https://www.linkedin.com/co mpany/thrombus-eu-project/ https://thrombus.eu/ thrombus-project@athenarc.eu Co-funded by the European Union