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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

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