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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
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Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.
In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR Band | Experimental | Each subject will have a Terumo TR Band applied to the wrist with MRI scans done at differing band pressure levels. The diameter of the radial artery will be measured at each level of band compression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR Band | Device | The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI Based Radial Artery Measurement | Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band. | Subjects will be followed up to one week post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Perfusion as Measured by Pulse Oxymetry Waveform | pulse oxymetry waveform will be used to measure arterial perfusion | Subjects will be followed up to one week post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Guimaraes, MD | Medical University of South Carolina | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | TR Band | MRI based radial artery measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TR Band | MRI based Radial artery measurement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MRI Based Radial Artery Measurement | Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band. | Posted | Mean | Full Range | millimeters | Subjects will be followed up to one week post procedure |
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from time of procedure until 1 week post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TR Band | MRI based radial artery measurement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment | Subject experienced approximately 10 seconds of dizziness when getting up from the MRI scanner table after the scans were completed. Dizziness resolved with no intervention. |
Single center study with small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gash, Director of Clinical Affairs | Terumo Medical Corporation | 732-302-4931 | robert.gash@terumomedical.com |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Hand Perfusion as Measured by Pulse Oxymetry Waveform | pulse oxymetry waveform will be used to measure arterial perfusion | Posted | Mean | Full Range | percent saturated | Subjects will be followed up to one week post procedure |
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PI shall be permitted to publish the results of the Study in a manner that fairly and accurately sets forth the conclusions reached. The party seeking publication shall submit to SPONSOR for review a draft of the proposed publication at least thirty (30) days prior to submission of the draft for publication.