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| Name | Class |
|---|---|
| Helptrial Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute ischemic stroke patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter, NIRSITX | 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. |
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea | |||
| Soonchunhyang University Hospital |
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.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Seoul |
| 04401 |
| South Korea |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |