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

NCT ID: NCT04983953

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-23

Study Completion Date

2021-07-28

Brief Summary

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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

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Conditions

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Intracranial Hemorrhages

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Abnormal

A patient diagnosed with intracranial haemorrhage after a brain CT scan

cHS

Intervention Type DEVICE

Clinical decision support system for diagnosing intracranial haemorrhage

Normal

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

cHS

Intervention Type DEVICE

Clinical decision support system for diagnosing intracranial haemorrhage

Interventions

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cHS

Clinical decision support system for diagnosing intracranial haemorrhage

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heuron Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HR-cHS-01

Identifier Type: -

Identifier Source: org_study_id

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