MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke

Evaluating the Validation of MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke : a Single-center, Single-arm, Single-blind (Evaluator), Retrospective Pivotal Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06160726

Enrollment

474

Registered

2023-12-07

Start date

2023-10-24

Completion date

2023-11-07

Last updated

2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Brief summary

This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT). Using the investigational device, analyze the image and the onset time of occurrence of acute ischemic stroke lesion on the brain image (4.5 hours or more from the onset of symptoms) and evaluate the efficacy of correctly estimating the onset time.

Detailed description

This clinical trial software medical device (Model name: NNS-SOT) is developed based on artificial intelligence algorithms. Through clinical validation, it will be easier to determine whether the golden hour (4.5 hours) has elapsed at the time of cerebral infarction in the medical field. It can be used for estimation of the onset time of occurrence in acute ischemic stroke.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Brain imaging in patients with acute ischemic stroke aged 20 years and older * Brain imaging of ischemic stroke manifestation lesion confirmed by medical staff in brain MR image * Brain imaging taken within 24 hours of ischemic stroke symptoms * Brain imaging including Magnetic Resonance(MR) images (DWI and FLAIR) * Patients with clearly recorded onset time of acute ischemic stroke symptoms

Exclusion criteria

* Brain imaging used in NNS-SOT development process * Brain imaging with noise (Artifact) * Brain images damaged in data

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity	October - November 2023	Evaluation of sensitivity and specificity of clinical performance (estimation of 4.5 hours or more after cerebral infarction) performed with clinical trial medical device

Secondary

Measure	Time frame	Description
Area Under the Curve(AUC), which is the lower area of the Receiver Operating Characteristics(ROC) curve	October - November 2023	Lower limit of 95% confidence interval is 80% or more

Countries

South Korea

Outcome results