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

Acute Ischemic Stroke Patients Clinical Trial

Official title:

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, Single-center, Non-randomized, Open-label, Exploratory Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250608
• Other study ID #: OBE-KMT22-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: OBELAB, Inc.
• Contact: Tae Jung Kim
• Phone: 82-2-2072-1810
• Email: ttae35[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke Patients
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
OBELAB, Inc.	Helptrial Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)