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NCT04983927 Clinical Trial

Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

Ischemic Stroke Clinical Trial

Official title:
An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04983927
Other study ID # HR-cASP-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 11, 2021
Est. completion date December 6, 2021

Study information
Verified date January 2022
Source Heuron Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.

Recruitment information / eligibility
Status Completed
Enrollment 326
Est. completion date December 6, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adults over 19 years old - Brain CT acquired Exclusion Criteria: - Patients with ischemic stroke in posterior circulation - Poor or incomplete brain CT image quality

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• cASPECTS
Clinical decision support system for scoring ASPECTS score

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon Namdong-gu

Sponsors (1)
Lead Sponsor Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences between ASPECTS scores in golden standard and in cASPECTS Mean difference between ASPECTS scores calculated by human experts and ASPECTS scores calculated by cASPECTS Within 4 weeks after collecting data
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