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

NCT06989255 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-05-25

No results posted yet for this study

Summary

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.

Conditions

  • Deep Vein Thrombosis

Sponsors & Collaborators

  • ThrombUS+

    lead OTHER

Principal Investigators

  • Eleni Kaldoudi, Prof. · ATHENA Research Center, Greece

  • Andrius Macas, Prof. Dr. · Lithuanian University of Health Science [Lietuvos Sveikatos Mokslu Universitetas], Lithuania

  • Michail Potoupnis, Prof. · School of Medicine, Aristotle University of Thessaloniki and Papageorgiou General Hospital, Greece

  • Elvira Grandone, Prof. · Home Relief of Suffering Hospital [Fondazione Casa Sollievo Della Sofferenza], Italy

  • Maxime Gautier, Dr. · Simon Veil Hospital, France

  • Savvas Defteraios, Prof. · University General Hospital of Alexandroupoli, Greece

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France
  • Greece
  • Italy
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989255 on ClinicalTrials.gov