WithdrawnNot Applicable

Benefit of Machine Learning to Diagnose Deep Vein Thrombosis Compared to Gold Standard Ultrasound

Stopped: abandoned before opening

United Kingdom0Started 2022-03-01

Plain-language summary

The study coordinator aims to compare gold standard deep vein thrombosis (DVT) diagnostic performed by a specialist sonographer to a scan by a non-specialist with a newly developed an automated DVT (AutoDVT) detection software device. The title of the project is: Benefit of Machine learning to diagnose Deep Vein thrombosis compared to gold standard Ultrasound. Currently the process from the DVT symptom begin, to diagnosis and then treatment is all but not straightforward. It implements a laborious journey for the patient from their general practitioner (GP) to accident and emergency (A\&E), then to a specialist sonographer. However, handheld Ultrasound devices have recently become available and they have been implemented with a machine learning software. The startup company ThinkSono developed a software which is hoped to divide between thrombosis and no thrombosis. In this single-blinded pilot study, patients which present at St Mary's DVT Clinic will be scanned by the specialist and then by a non-specialist with the machine learning supported device. The accuracy and sensitivity of this device will be compared to the gold standard. This would mean that DVT could be diagnosed at point of care by a non-specialist such as a community nurse or nursing home nurse, for example beneficial for multimorbid confused nursing home patients. This technology could reduce A\&E crowding and free up specialist sonographer to focus on other clinical tasks. These improvements could significantly reduce the financial burden for the National Health System (NHS). The AutoDVT has a CE (as the logo CЄ, which means that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards) Certificate under the directive 93/42/ European Economic Community (EEC) for medical devices. It is classified in Class 1 - Active Medical Device - Ultrasound Imaging System Application Software (40873). Furthermore, following standards and technical specifications have been applied: British Standard (BS) European Norm (EN) International Organisation for Standardisation (ISO) 13485:2016, BS EN ISO 14971:2012, Data Coordination Board (DCB)0129:2018, ISO 15233-1:2016.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The participant has capacity to consent and consent is obtained
. The participant is an adult (18 or older in the UK)
. The participant has symptoms suggestive of a deep venous thrombosis
. The diagnostic DVT algorithm indicates that an ultrasound is needed

Exclusion criteria

. Participant cannot consent
. Participant is under age of 18
. No data of D-dimer result

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of AutoDVT diagnostic software compared to diagnose by a trained sonographer

Timeframe: Day 1, no follow up

Trial details

NCT IDNCT05288413

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-01

View on ClinicalTrials.gov More Deep Venous Thrombosis of Leg trials