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

February 6, 2024 updated by: OBELAB, Inc.

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sang-Bae Ko
        • Sub-Investigator:
          • Tae Jung Kim
        • Sub-Investigator:
          • Giljun Suh
        • Sub-Investigator:
          • Woon Yong Kwon
        • Sub-Investigator:
          • Taegyun Kim
        • Sub-Investigator:
          • Yoon Sun Jung
        • Sub-Investigator:
          • Hayoung Kim
        • Sub-Investigator:
          • Hee Su Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute ischemic stroke patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Baseline and follow-up (24 hours later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OBELAB, Inc.

Collaborators

Helptrial Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 13, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBE-KMT22-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators must keep confidential all information related to the clinical trial protocol provided by the sponsor or clinical trial monitor. However, exceptions are made when disclosure is requested by the Institutional Review Board, research subjects, or health authorities pursuant to laws or related regulations.

Personal information of research subjects who participated in clinical trials will be used for up to 6 months after the end of clinical trials, and the collected information will be appropriately managed in accordance with the Personal Information Protection Act. This personal information is not provided to anyone other than the tester.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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