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Comparing AutoDVT software with specialists in diagnosing blood clots

Evaluation of the diagnostic exclusion ability of the AutoDVT software for an algorithm-guided compression sonography in comparison to conventional compression sonography by experienced specialists

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55099449
Enrollment
30
Registered
2023-05-12
Start date
2021-10-08
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

An AI-assisted scan with the AutoDVT software is performed by a non-specialist. A follow-up gold-standard scan is performed by a local specialist (compression ultrasound). The images collected by the

Sponsors

ThinkSono GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: at least 18 years old, of both sexes 2. Suspicion of the presence of a deep vein thrombosis, indicating a compression ultrasound exam according to standard clinical practice 3. Capacity to consent in the study through the patients or the legal Representative

Exclusion criteria

Exclusion criteria: Inability to the consent in the study or rejection through patients or the legal representative.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity compared between the AI-guided ultrasound and local imaging specialist performing the gold-standard ultrasound exam. The gold-standard exam is performed on the same day

Secondary

MeasureTime 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. The overall proportion will be reported.

Countries

Germany

Outcome results

None listed

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