A pilot study to evaluate AI-assisted ultrasound software for the diagnosis of venous thrombosis

Not Applicable

Completed

• Conditions: Proximal deep vein thrombosis; Circulatory System

• Registration Number: ISRCTN24293748
• Lead Sponsor: ThinkSono GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-01
• Study Start: 2023-05-13
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged 18 years old and over
2. Suspicion of the presence of a deep vein thrombosis, indicating a compression ultrasound exam according to standard clinical practice
3. Capacity to consent to the study through the patients or the Legal Representative

Exclusion Criteria

1. Inability to consent to the study or rejection through patients or the legal representative.
2. Pregnant for more than 12 weeks
3. D-dimer testing cannot be performed/patient is on anticoagulation
4. History of DVT in the symptomatic leg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity measured using AI-guided ultrasound and a local imaging specialist performing the gold-standard ultrasound exam at the same timepoint

Secondary Outcome Measures

Name	Time	Method
Image quality of the AI-guided ultrasound measured by a remote qualified clinician according to the American College of Emergency Physicians (ACEP) scoring scale from 1 to 5 at one timepoint