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

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.

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Key information

Conditions

Intracranial Hemorrhages Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cHS

Device

Clinical decision support system for diagnosing intracranial haemorrhage

Primary outcomes

Sensitivity and specificity of cHS

Time frame: Within 4 weeks after collecting data

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

Sponsors and collaborators

Lead sponsor

Heuron Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jul 30, 2021
Registry last updated: Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed