Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images

Heuron

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: 1st Reading; Device: 2nd Reading

Study type: Observational

Funder types: Industry

Identifiers

NCT05572619

HR-cELVO-01

Details and patient eligibility

About

cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.

Enrollment: 479 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 19 years old
• Brain non-contrast CT, CT perfusion and CT angiography acquired
• Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
• Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography

Exclusion criteria

• Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality

Trial design

479 participants in 2 patient groups

Positive group

Description:

A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography

Treatment:

Device: 2nd Reading

Device: 1st Reading

Negative group

Description:

A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography

Treatment:

Device: 2nd Reading

Device: 1st Reading