Benefit of machine learning to diagnose deep vein thrombosis compared to the gold standard ultrasound

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN24147434

Enrollment

Registered

2023-05-15

Start date

2022-04-18

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal deep vein thrombosis Circulatory System

Interventions

Patient recruitment Patients will consent when a DVT ultrasound exam is requested in the angiology department. An AI-assisted scan with the AutoDVT software is performed by a non-specialist (nurse).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old and over 2. Subject can consent and consent has been signed 3. Subject has symptoms of DVT and ultrasound is indicated

Exclusion criteria

Exclusion criteria: 1. Below the age of 18 years old 2. No Wells score was calculated prior to the ultrasound 3. Distal DVT 4. Did not consent

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity measured using the AI-guided ultrasound and a local imaging specialist performing the gold-standard ultrasound exam at one timepoint. The gold-standard exam is performed on the same day.	—

Secondary

Measure	Time frame
Image quality of the AI-guided ultrasound assessed by remote qualified clinicians, according to the American College of Emergency Physicians (ACEP) scoring scale from 1 to 5, at one timepoint	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026