Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images

Heuron

Status: Completed

Conditions: Intracranial Hemorrhages

Treatments: Device: cHS

Study type: Observational

Funder types: Industry

Identifiers

NCT04983953

HR-cHS-01

Details and patient eligibility

About

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

The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.

Enrollment: 236 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 19 years old
• Brain CT acquired
• Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
• Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan

Exclusion criteria

• Patients with brain tumor or cerebral toxoplasmosis
• Patients with brain abscess or brain calcification
• Poor or incomplete brain CT image quality

Trial design

236 participants in 2 patient groups

Abnormal

Description:

A patient diagnosed with intracranial haemorrhage after a brain CT scan

Treatment:

Device: cHS

Normal

Description:

A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan

Treatment:

Device: cHS