ThrombUS+ D7.4: Report on Status of Posting of Results – Study A

D7.4. Report on Status of Posting of Results – Study A S. Didaskalou [ATHENA], N. Portokallidis [ATHENA], I. Drougka [PHAZE], E. Kaldoudi [ATHENA] Due Date: 31 Mar 2025 Delivery Date: 25 Nov 2025 Horizon Innovation Action | Agreement No. 101137227 HORIZON-HLTH-2023-TOOL-05-05 Co-funded by the European Union D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 ii ThrombUS+ Consortium ATHENA Research and Innovation Center in Information, Communication and Knowledge Technologies, Greece Eleni Kaldoudi [email protected] KTU Kaunas University of Technology Lithuania Vaidotas Marozas [email protected] VERMON Vermon SA France Mathieu Legros [email protected] FRAUNHOFER Institute for Photonic Microsystems, Fraunhofer Germany Nicolas Lange [email protected] TELEMED Telemed Ultrasound Medical Systems Lithuania Dmitry Novikov [email protected] EchoNous EchoNous Inc USA Pavlos Moustakidis [email protected] MEDIS medis Medizinische Messtechnik GmbH Germany Susann Balling [email protected] ComfTech ComfTech SLR Italy Lara Alessia Moltani [email protected] TAU Faculty of Medicine and Health Technology Tampere University, Finland Antti Vehkaoja [email protected] LMSU Lithuanian University of Health Science Lithuania Andrius Macas [email protected] GNP Papageorgiou General Hospital Greece Maria Bigaki [email protected] CSS-IRCCS Home Relief of Suffering Hospital Italy Elvira Grandone e.grand[email protected] HSV Simon Veil Hospital France Maxime Gautier [email protected] VDE Association for Electrical, Electronic & Information Technologies, Germany Thorsten Prinz thorsten.pri[email protected] MEDEA MEDEA SRL Italy Pietro Dionisio [email protected] PHAZE Clinical Research and Pharma Consulting SA Greece Spiros Anagnostopoulos [email protected] PBY PredictBy Research and Consulting SL Spain Frans Folkvord [email protected] SciGen SciGen Technologies SA Greece Katerina Pavlidi [email protected] Disclaimer This document contains description of the ThrombUS+ project work, findings, and products. The authors of this document have taken any available measure for its content to be accurate, consistent and lawful. However, neither the project consortium as a whole nor the individual partners that implicitly or explicitly participated in the creation and publication of this document hold any sort of responsibility that might occur as a result of using its content. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or HADEA. Neither the European Union nor the granting authority HADEA can be held responsible for them. In case you believe that this document harms in any way intellectual property held by you as a person or as a representative of an entity, please do notify us immediately. ThrombUS+ is an Innovation Action Project co-funded by the European Union, under HORIZON-HLTH-2023-TOOL05-05 “Harnessing the potential of real-time data analysis and secure Point-of-Care computing for the benefit of person-centred health and care delivery”. D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 iii Document Control Page Project Grant Agreement: 101137227 Acronym: ThrombUS+ Title: Wearable Continuous Point-of-Care Monitoring, Risk Estimation and Prevention for Deep Vein Thrombosis Type: Innovation Action Start: 1 January 2024 End: 30 June 2027 Programme: Horizon Europe Call Identifier: HORIZON-HLTH-2023-TOOL-05-05 Call Topic Harnessing the potential of real-time data analysis and secure Point-of-Care computing for the benefit of person-centred health and care delivery Website: http://thrombus.eu/ Deliverable # 24 No: D7.4 Deliverable Title: Report on Status of Posting of Clinical Studies - Study A Deliverable Type: R Classification: PU Task: T7.2. Clinical Study A – conventional US data collection Task Leader: PHAZE [I. Drougka] Work Package: 7. Clinical studies [M01-M42] Work Package Leader: PHAZE [I. Drougka] Responsible Partner: PHAZE Authors: S. Didaskalou [ATHENA], N. Portokallidis [ATHENA], I. Drougka [PHAZE], E. Kaldoudi [ATHENA] Input from: Clinical partners Peer Reviewers: T. Prinz [VDE], A. Fiska [ATHENA] Due Date: 31 Mar 2025 [M15] Delivery Date: 25 Nov 2025 Document Status Version: 1.0 Status: Draft Consortium reviewed WP leader endorsed Coordinator endorsed D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 iv Revision History Version Date Modification Contributors 0.1 10 Nov 2025 New content, deliverable layout E. Kaldoudi [ATHENA] 0.2 15 Nov 2025 ISF, Version 1.0_26sep2024/ TMF, Version 1.0_26sep2024 I. Drougka [PHAZE] 0.3 20 Nov 2025 Study A data set description S. Didaskalou [ATHENA] N. Portokallidis [ATHENA] 0.4 25 Nov 2025 Comments from reviewers T. Prinz [VDE], A. Fiska [ATHENA] 1.0 25 Nov 2025 Editing for conformity E. Kaldoudi [ATHENA] D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 v Contents About ThrombUS+ ...................................................................................................................................................... 1 Deliverable D7.4 Description ...................................................................................................................................... 1 Cite this Document as ................................................................................................................................................. 1 Terms and Definitions................................................................................................................................................. 2 Executive Summary .................................................................................................................................................... 3 1. Study A Registration and Posting of Results ....................................................................................................... 4 2. Study A Progress and Plan for Completion ......................................................................................................... 5 ANNEX: ThrombUS+ Study A Data Set #1 ................................................................................................................... 7 Data collection overview ................................................................................................................................................ 7 Data set #1 overview ...................................................................................................................................................... 8 Overview of the Training and Testing Subsets ............................................................................................................. 10 D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 1 About ThrombUS+ 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. Deliverable D7.4 Description 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 report on the posting of the current status of the posting of results of Study A. Cite this Document as Didaskalou S, N Portokallidis, Drougka I, Kaldoudi E, Report on Status of Posting of Results – Study A, Deliverable 7.4, ThrombUS+ Horizon Europe Innovation Action, EC Grant Agreement No. 101137227, 25 November 2025, https://doi.org/10.5281/zenodo.17641971 D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 2 Abbreviations and Definitions Abbreviation Definition CSV Comma separated values CVF Common femoral vein DICOM Digital Imaging and Communications in Medicine DVT Deep Vein Thrombosis FV Femoral vein GSV Great saphenous vein L Left ID Identification PGNA University General Hospital of Alexandroupoli, Greece Pop Popliteal vein PV Popliteal vein R Right SD Standard deviation US Ultrasound D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 3 Executive Summary The ThrombUS+ Study A is registered on ClinicalTrials.gov (ID: NCT06989255). The resulting data, protocol, and manuals are deposited in Zenodo and shared on Kaggle. Software for data anonymization developed for the purposes of the study is available as open source via GitHub. D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 4 1. Study A Registration and Posting of Results ThrombUS+ Clinical Study A is registered in ClinicalTrials.gov platform, ID: NCT06989255. Protocol, data collection and annotation manual and resulting data sets are also deposited in Zenodo. The first Study A dataset is publicly available in ThrombUS+ community in Zenodo. The dataset and its description are also posted on the Kaggle 1 as part of the 1st data challenge organized by the ThrombUS+ consortium. Ultrasound DICOM data anonymizer software is available via GitHub. A detailed account of the Study A outcomes and posting status is given in the table below. ThrombUS+ Study A registration and posting of results Study A outcome Platform Date Link Protocol ClinicalTrials.gov 25.05.2025 https://clinicaltrials.gov/study/NCT06989255?term=Th rombUS%20Study-A&rank=1 Protocol Zenodo 28.05.2024 https://doi.org/10.5281/zenodo.11371924 Ultrasound Data Collection Manual Zenodo 20.08.2025 https://doi.org/10.5281/zenodo.16913651 Ultrasound Data Annotation Manual Zenodo 20.08.2025 https://doi.org/10.5281/zenodo.16912105 Ultrasound Data Anonymizer GitHub 26.05.2025 https://github.com/thrombusplus/US-DICOMizer Training data set #1 Zenodo 21.11.2025 https://doi.org/10.5281/zenodo.17659415 Testing data set #1 Zenodo 21.11.2025 https://doi.org/10.5281/zenodo.17664207 Challenge 1.1. on Training and Testing data set #1 Kaggle 25.11.2025 https://www.kaggle.com/competitions/Thrombus_cha llenge_1_1 Challenge 1.1. on Training and Testing data set #1 Kaggle 25.11.2025 https://www.kaggle.com/competitions/Thrombus_cha llenge_1_2 Training data set #2 Zenodo June 2026 pending Testing data set #2 Zenodo June 2026 pending Training data set #3 Zenodo Feb 2027 pending Testing data set #3 Zenodo Feb 2027 pending Complete data set with ground truth Zenodo ClinicalTrials.gov Feb 2029 pending The first set of results of Study A that have already been posted is the ThrombUS+ Training and Testing Data Set #1, which contains 2 separate data sets: a training data set and atTesting data set. The training dataset includes 2341 anonymized compression ultrasound videos from 4 anatomical sites on the leg, acquired from 1 Kaggle (https://www.kaggle.com) is the world's leading online platform and community for data science and machine learning. It was founded in 2010 and is now a subsidiary of Google. It features more than 500,000 data sets submitted by the public and has held more than 10,000 competitions. There are more than 27 million user accounts. D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 11 respect to the 5 contributing clinical sites. Figure 6E and Figure 6F present the distribution of videos per left or right leg in the training and testing subsets respectively Although data stratification was performed so as to ensure as much as possible similar distributions of videos per anatomical site, right-left leg and DVT or non-DVT in the training and testing subsets, the exact distributions are not disclosed at this time so as to maintain scientific rigor and prevent data dredging in the challenge that is organized based on these data. The full detailed description of the stratification into training and testing data subsets will be disclosed after the completion of the respective data challenge, in the data description in Zenodo. Figure 5. Overview of ThrombUS+ Study A Data Set #1 as split in Training and Testing subsets. Left column presents the demographics and biometrics distribution of the patients contributing data for the training subset while the right column the respective distributions for the testing subset. D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 12 Figure 6. Overview of ThrombUS+ Study A Data Set #1 as split in Training and Testing subsets. (A) and (B) present patient provenance in the training and testing subsets respectively; (C) and (D) present video provenance in the training and testing subsets respectively; and (E) and (F) present the distribution of videos per left or right leg in the training and testing subsets respectively. D7.4| Study A Posting of Results v1.0 | 25 Nov 2025 13 Download ThrombUS+ Data Set #1: Training subset #1: https://zenodo.org/records/17659415 Testing subset #1: https://zenodo.org/records/17664207