Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.

NCT06250608 | Completed

• 1 other identifier: OBE-KMT22-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain. The purpose of the clinical trial is to compare differences in cerebral oxygen saturation values, and the efficacy and safety are evaluated through additional exploratory clinical trials.

Conditions

Acute Ischemic Stroke Patients

Keywords

Stroke; Ischemic Stroke; Acute Ischemic Stroke; Cerebral Oxygen Saturation(rSO2)

Outcome Measures

Primary Outcomes (1)

• Comparison of rSO2 values obtained from NIRSITX, a medical device for clinical trials, between the frontal lobe on the side with brain lesions and the frontal lobe on the contralateral side.

  The number of study subjects, mean, standard deviation, median, minimum, and maximum are presented as descriptive statistics for the difference and rate of change in rSO2 values obtained from medical equipment for clinical trials between the frontal lobe on the side with the brain lesion and the frontal lobe on the contralateral side. The statistical significance of the change in rSO2 values between two areas is tested using the t-test or Wilcoxon test.

  Baseline and follow-up (24 hours later)

Study Arms (1)

Acute ischemic stroke patients

EXPERIMENTAL

Device: Pulse oximeter, NIRSITX

Interventions

Pulse oximeter, NIRSITX DEVICE

It is a device that non-invasively continuously monitors blood oxygen saturation (rSO2) in localized areas of the brain. This device is attached to patients with symptoms suspected of stroke or diagnosed with stroke to continuously monitor the level of oxygen supply to the brain.

Acute ischemic stroke patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over age 19
• Patients diagnosed with acute ischemic stroke within 7 days of symptom onset
• Patient's condition confirmed to have an acute ischemic stroke and also brain blood vessels condition confirmed through brain imaging such as Brain CT/CTA/CT perfusion and Brain MRI/MRA
• Patients voluntarily agree to participate and scheduled to participate in this clinical trial
• Patients willing to comply with the clinical trial protocol

You may not qualify if:

• Patients without brain imaging result
• Patients diagnosed with jaundice (hyperbilirubinemia) with abnormal skin color - Patients who find it difficult to wear medical devices for clinical trial on their foreheads
• Patients who has skull fractures of external shape not maintained normal
• Patients who does not agree to participate in this clinical trial
• Patients who are currently participating in another clinical trial or have participated in another clinical trial within 30 days of the screening date
• Patients who is determined from investigator that participating is inappropriate because it may affect the results of the clinical trial or ethically

Sponsors & Collaborators

• OBELAB, Inc.: lead
• Helptrial Inc.: collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 9, 2024
• Study Start: March 15, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)