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

Not Applicable

Completed

• Conditions: Proximal deep vein thrombosis; Circulatory System

• Registration Number: ISRCTN24147434
• Lead Sponsor: ThinkSono GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-01
• Study Start: 2023-05-15
• Last Update Posted: 13 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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