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

Heuron Inc.236 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

236

Conditions

Intracranial Hemorrhages

Interventions

cHSDEVICE

Clinical decision support system for diagnosing intracranial haemorrhage

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Outcomes

Primary Outcomes

Sensitivity and specificity of cHS

Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards

Time frame: Within 4 weeks after collecting data

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.