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

Intracranial Hemorrhages Clinical Trial

Official title:

An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983953
• Other study ID #: HR-cHS-01
• Status: Completed
• Start date: June 23, 2021
• Est. completion date: July 28, 2021

Study information

• Verified date: January 2022
• Source: Heuron Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Intervention

Device:
• cHS
Clinical decision support system for diagnosing intracranial haemorrhage

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Namdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of cHS	Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards	Within 4 weeks after collecting data