Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Terumo Medical Corporation
- Enrollment
- 4
- Primary Endpoint
- MRI Based Radial Artery Measurement
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female or male adult (has reached the legal majority age).
- •Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.
Exclusion Criteria
- •Abnormal result of either baseline Barbeau or reverse Barbeau tests.
- •Pregnant or breast feeding female.
- •Subject with contraindication to MRI
Arms & Interventions
TR Band
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.
Intervention: TR Band (Device)
Outcomes
Primary Outcomes
MRI Based Radial Artery Measurement
Time Frame: Subjects will be followed up to one week post procedure
Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.
Secondary Outcomes
- Hand Perfusion as Measured by Pulse Oxymetry Waveform(Subjects will be followed up to one week post procedure)