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CompletedNCT04983953Updated Jan 14, 2022

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

An observational study in Intracranial Hemorrhages, sponsored by Heuron Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-01-14.

Sponsored by Heuron Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
236
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Intracranial Hemorrhages
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In context

Intracranial Hemorrhages

199 studies on the registry are indexed under Intracranial Hemorrhages; 64 are open to participants now.

This study's enrollment of 236 is close to the median of 240 across 87 observational studies indexed under Intracranial Hemorrhages.

Browse Intracranial Hemorrhages studies →

Lead sponsor

Heuron Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

Exclusion Criteria:

  • Patients with brain tumor or cerebral toxoplasmosis
  • Patients with brain abscess or brain calcification
  • Poor or incomplete brain CT image quality
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
236 participants (actual)
Patient registry
No

Groups and cohorts

  • Abnormal

    A patient diagnosed with intracranial haemorrhage after a brain CT scan

    Device: cHS

  • Normal

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

    Device: cHS

Interventions

  • DevicecHS

    Clinical decision support system for diagnosing intracranial haemorrhage

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What researchers measure

Primary outcomes

  1. Sensitivity and specificity of cHS

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

    Time frame: Within 4 weeks after collecting data

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Study locations

1 site
  • Gachon University Gil Medical Center
    Incheon, Namdong-gu 21565, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04983953
Lead sponsor
Heuron Inc.
Responsible party
Sponsor
First posted
Jul 30, 2021
Start date
Jun 23, 2021
Primary completion
Jul 28, 2021
Completion
Jul 28, 2021
Last update
Jan 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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