ClinicalTrials.gg
CompletedNCT06160726Updated Dec 7, 2023

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

An observational study in Acute Ischemic Stroke, sponsored by Nunaps Inc. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Nunaps Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
474
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 474 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Nunaps Inc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cerebral infarction disease Brain imaging data taken from 474 subjects who visited clinical trial institution (From 2017 to March 27, 2023)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Brain imaging used in NNS-SOT development process
  • Brain imaging with noise (Artifact)
  • Brain images damaged in data
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
474 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: October - November 2023

Secondary outcomes

  1. 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

    Time frame: October - November 2023

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Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2023 to primary completion in Nov 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2023
First posted
Dec 7, 2023
StartActual
Oct 24, 2023
Primary completionActual
Nov 7, 2023
CompletionActual
Nov 7, 2023
Last update
Dec 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06160726
Lead sponsor
Nunaps Inc
Responsible party
Sponsor
First posted
Dec 7, 2023
Start date
Oct 24, 2023
Primary completion
Nov 7, 2023
Completion
Nov 7, 2023
Last update
Dec 7, 2023

Study contacts

Bum Joon Kim, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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