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

NCT ID: NCT06250608

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Acute ischemic stroke patients

Group Type EXPERIMENTAL

Pulse oximeter, NIRSITX

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helptrial Inc.

UNKNOWN

Sponsor Role collaborator

OBELAB, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae Jung Kim

Role: CONTACT

Phone: 82-2-2072-1810

Email: [email protected]

Seojin Pyo

Role: CONTACT

Phone: 82-10-3002-4378

Email: [email protected]

Facility Contacts

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Tae Jung Kim

Role: primary

Youjin Song, CRC

Role: backup

Other Identifiers

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OBE-KMT22-01

Identifier Type: -

Identifier Source: org_study_id