NCT06160726

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

14 days

First QC Date

November 29, 2023

Last Update Submit

November 29, 2023

Conditions

Acute Ischemic Stroke

Outcome Measures

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

    October - November 2023

Secondary Outcomes (1)

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

    October - November 2023

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bum Joon Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

October 24, 2023

Primary Completion

November 7, 2023

Study Completion

November 7, 2023

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

KR(1)