Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
Completed
- Conditions
- Intracranial Hemorrhages
- Interventions
- Device: cHS
- Registration Number
- NCT04983953
- Lead Sponsor
- Heuron Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Abnormal cHS A patient diagnosed with intracranial haemorrhage after a brain CT scan Normal cHS A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of cHS Within 4 weeks after collecting data Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of