New brain oxygen monitor could help stroke doctors spot damage faster
NCT ID NCT06250608
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called NIRSITX that uses light to measure oxygen levels in the brain. Researchers compared oxygen readings from the injured side of the brain to the healthy side in 35 adults who had a stroke within the past week. The goal was to see if the device could detect differences that might help doctors monitor stroke patients more closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NIRSITX pulse oximeter (near-infrared spectroscopy device)
- What this could lead to
- If successful, this device could help doctors quickly assess brain oxygen levels in stroke patients, potentially improving monitoring and treatment decisions.
- What could go wrong
- This was a small, early exploratory study with only 35 participants. The device may not reliably distinguish injured from healthy brain tissue in real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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35 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seoul National University Hospital
Seoul, 03080, South Korea
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Soonchunhyang University Hospital
Seoul, 04401, South Korea
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