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Completed

NCT Number: NCT06160726

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity

    Time frame: 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 outcomes

  1. Area Under the Curve(AUC), which is the lower area of the Receiver Operating Characteristics(ROC) curve

    Time frame: October - November 2023

    Lower limit of 95% confidence interval is 80% or more

Sponsors and collaborators

Lead sponsor

Nunaps Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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