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NCT06160726 Clinical Trial

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

Acute Ischemic Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06160726
Other study ID # NNS-SOT-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 24, 2023
Est. completion date November 7, 2023

Study information
Verified date November 2023
Source Nunaps Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 474
Est. completion date November 7, 2023
Est. primary completion date November 7, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Nunaps Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity Evaluation of sensitivity and specificity of clinical performance (estimation of 4.5 hours or more after cerebral infarction) performed with clinical trial medical device October - November 2023
Secondary Area Under the Curve(AUC), which is the lower area of the Receiver Operating Characteristics(ROC) curve Lower limit of 95% confidence interval is 80% or more October - November 2023
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