Deep vein thrombosis and pulmonary embolism.
Marcello Di Nisio, Nick van Es, Harry R Büller
https://pubmed.ncbi.nlm.nih.gov/27375038Actively Recruiting
Age: 18Years +
All Genders
ID06989255
A Multi-center Cohort Study for Conventional Ultrasound Image Set Collection to Create a Training Data Set for Research Purposes (Image Processing and Analysis, AI Model Training).
Led by ThrombUS+ · Updated on 2025-05-25
3000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and creating a labeled ultrasound image data set from patients undergoing routine ultrasound scans of their lower limbs due to suspected deep vein thrombosis (DVT). This observational study aims to gather imaging data, patient information, and ultrasound metadata to train artificial intelligence (AI) models that can automatically detect DVT from conventional ultrasound scans. The study is part of the ThrombUS+ project, which focuses on developing tools for early and automated DVT diagnosis to improve patient safety and outcomes. The study involves selecting patients suspected of having DVT who are referred for ultrasound scans. These patients, both inpatients and outpatients, will be consecutively included to ensure diversity of demographics, medical conditions, and ultrasound operators. The collected data will include ultrasound image series and video clips, along with anonymized patient demographics, referral notes, medical conditions, scan diagnoses, operator IDs, and ultrasound equipment details. The anonymized data set will be prepared according to regulations for research use and shared publicly through European science portals. Participants will undergo routine ultrasound scans for suspected DVT, and their scan data and related information will be collected and anonymized. The primary outcome is the ultrasound data collected on the day of the scan. The data set will support AI model training and research, with the anonymized information made available for further study. Participation involves providing informed consent and allowing the inclusion of their scan data and metadata. The study will monitor data quality and maintain privacy throughout, with no interventional treatments involved.
CONDITIONS
Brief Title
A Multi-center Cohort Study for Conventional Ultrasound Image Set Collection to Create a Data Set for Research Purposes.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age �318 years.
- Ability to provide informed consent before any study procedures.
- Ultrasound scan indicated by diagnostic DVT algorithm or referral due to suspected DVT.
You will not qualify if you...
- Condition that may cause stopping the ultrasound exam before completion.
- Considered unsuitable for a standard ultrasound scan by physician or operator.
- Not having signed informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during which informed consent is obtained and eligibility is confirmed
Diagnostic Evaluation
Duration - 1 day
Participants undergo a routine ultrasound scan of the lower limbs to collect imaging data for research purposes.
1 visit (in-person) for ultrasound imaging
Long-term Monitoring
Duration - Up to study completion (approximately 2 years)
Anonymized ultrasound data and participant information are monitored and used for AI model training and research.
No additional participant visits; data are collected from routine care
Trial Site Locations
Total: 5 locations
1
Groupement Hospitalier Eaubonne Montmorency Simone Veil
Montmorency, France, 95160
Actively Recruiting
2
University General Hospital of Alexandroupoli
Alexandroupoli, Greece, GR 68100
Actively Recruiting
3
Papageorgiou General Hospital
Thessaloniki, Greece, 54603
Actively Recruiting
4
Home Relief of Suffering Hospital
San Giovanni Rotondo, Italy, FG 71013
Actively Recruiting
5
Lithuanian University of Health Science
Kaunas, Lithuania, 44307
Actively Recruiting
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Research Team
E
Eleni Kaldoudi, Prof.
S
Stelios Didaskalou, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The epidemiology of venous thromboembolism.
John A Heit, Frederick A Spencer, Richard H White
https://pubmed.ncbi.nlm.nih.gov/26780736Thrombosis: a major contributor to the global disease burden.
ISTH Steering Committee for World Thrombosis Day
https://pubmed.ncbi.nlm.nih.gov/25302663Prevention of Venous Thromboembolism in 2020 and Beyond.
Matthew Nicholson, Noel Chan, Vinai Bhagirath...
https://pubmed.ncbi.nlm.nih.gov/32752154Screening for deep vein thrombosis in asymptomatic high-risk patients: a comparison between digital photoplethysmography and venous ultrasonography.
Babak Sharif-Kashani, Neda Behzadnia, Payman Shahabi...
https://pubmed.ncbi.nlm.nih.gov/18854340