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

January 12, 2022 updated by: Heuron Inc.

An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Namdong-gu
      • Incheon, Namdong-gu, Korea, Republic of, 21565
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

(1) Adults over 19 years old (2) Brain CT images acquired (3) who confirmed with intracranial haemorrhage(abnormal cohort) or not intracranial haemorrhage or normal(normal cohort)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abnormal
A patient diagnosed with intracranial haemorrhage after a brain CT scan
Device: cHS
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
Device: cHS
Clinical decision support system for diagnosing intracranial haemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 4 weeks after collecting data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heuron Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Actual)

July 28, 2021

Study Completion (Actual)

July 28, 2021

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-cHS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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