- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983953
Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Namdong-gu
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Incheon, Namdong-gu, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Clinical decision support system for diagnosing intracranial haemorrhage
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Normal
A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan
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Clinical decision support system for diagnosing intracranial haemorrhage
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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
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Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards
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Within 4 weeks after collecting data
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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