NCT06160726

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
• Phase: —
• Study type: Observational
• Enrollment: 474 (actual)
• Sponsor: Nunaps Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Timeline

• Start date: 2023-10-24
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2023-12-07
• Last updated: 2023-12-07

Locations

1 site across 1 country: South Korea