Trials / Completed
CompletedNCT04983953
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 236 (actual)
- Sponsor
- Heuron Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cHS | Clinical decision support system for diagnosing intracranial haemorrhage |
Timeline
- Start date
- 2021-06-23
- Primary completion
- 2021-07-28
- Completion
- 2021-07-28
- First posted
- 2021-07-30
- Last updated
- 2022-01-14
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04983953. Inclusion in this directory is not an endorsement.