NCT06250608

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

Evaluation of Cerebral Oxygen Saturation(rSO2) Measurements Between Frontal Lesion Area and Normal Area of Brain by Pulse Oximetry(NIRSITX) Using Near-infrared Spectroscopy in Acute Ischemic Stroke Patients, Prospective, Multi-center, Non-randomized, Open-label, Exploratory Clinical Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: OBELAB, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Pulse oximeter, NIRSITX	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.

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-12-27
• Completion: 2026-03-31
• First posted: 2024-02-09
• Last updated: 2026-01-07

Locations

2 sites across 1 country: South Korea