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

NCT ID: NCT06160726

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

474 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-24

Study Completion Date

2023-11-07

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nunaps Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bum Joon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NNS-SOT-01

Identifier Type: -

Identifier Source: org_study_id