A Multi-center Cohort Study for Conventional Ultrasound Image Set Collection to Create a Data Set for Research Purposes.

This study aims to collect and create a labelled ultrasound image data set containing ultrasound image series and video clips of patients that undergo routine ultrasound scans on lower limbs, because of suspected deep vein thrombosis. The data will be used to train an AI model within ThrombUS+ project to achieve automated detection of deep vein thrombosis on conventional ultrasound scans. Primary objectives: 1. Collect and curate imaging data from ultrasound scans of patients suspected for DVT. 2. Collect accompanying metadata on patient demographics, referral note, existing known medical conditions at the time of scan, diagnosis based on the scan, operator anonymized ID, metadata on the ultrasound equipment used. 3. Anonymize the data set according to established regulations to be used for research purposes and in specific for training an artificial intelligence model to achieve automated DVT detection. Secondary objectives: 1\. Describe the data set in the Argos/OpenAIRE tool and make it publicly available through the European Open Science Cloud (EOSC) portal via OpenAIRE, to be used by other researchers for image processing, analysis, and artificial intelligence (AI) model training.

NCT Number	NCT06989255
Lead Sponsor	ThrombUS+
Conditions	Deep Vein Thrombosis
Enrollment	3,000 participants
Start Date	2024-11-06
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-25