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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke Patients
• Interventions: Device: Pulse oximeter, NIRSITX

• Registration Number: NCT06250608
• Lead Sponsor: OBELAB, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-09
• Study Start: 2024-03-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke patients	Pulse oximeter, NIRSITX	-

Primary Outcome Measures

Name	Time	Method
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.	Baseline and follow-up (24 hours later)	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of