Acute Ischemic Stroke PatientsfNIRSNCT06250608
Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.
A study testing Pulse oximeter, NIRSITX in people with Acute Ischemic Stroke Patients, run by OBELAB, Inc. at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke Patients
- What is being tested?
- Pulse oximeter, NIRSITX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Mar 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Soonchunhyang University Hospital
Seoul, 04401
About this study
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, Multi-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.
- Conditions
- Acute Ischemic Stroke Patients
- Being tested
- Pulse oximeter, NIRSITX
- Keywords
- Stroke, Ischemic Stroke, Acute Ischemic Stroke, Cerebral Oxygen Saturation(rSO2)
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeter, NIRSITXDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients | Experimental | Not described Receives: Device: Pulse oximeter, NIRSITX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and follow-up (24 hours later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Mar 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- OBELAB, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helptrial Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250608
- Sponsor's protocol ID
- OBE-KMT22-01
- Acronym
- fNIRS
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Multi-center, Non-randomized, Open-label, Exploratory Clinical Trial.
- ClinicalTrials.gov ID
- NCT06250608
- Acronym / sponsor ID
- fNIRS / OBE-KMT22-01
- Conditions
- Acute Ischemic Stroke Patients
- Keywords
- Stroke, Ischemic Stroke, Acute Ischemic Stroke, Cerebral Oxygen Saturation(rSO2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- OBELAB, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Helptrial Inc.
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients | Experimental | Device: Pulse oximeter, NIRSITX |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeter, NIRSITXIt 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. | Device | Acute ischemic stroke patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Acute Ischemic Stroke Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter, NIRSITX in people with Acute Ischemic Stroke Patients, run by OBELAB, Inc. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.