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OpenTrials
Completed

NCT Number: NCT02478671

Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

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.

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Key information

Conditions

Poor Peripheral Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR Band

Device

The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured

Primary outcomes

  1. 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

  1. Hand Perfusion as Measured by Pulse Oxymetry Waveform

    Time frame: Subjects will be followed up to one week post procedure

    pulse oxymetry waveform will be used to measure arterial perfusion

Sponsors and collaborators

Lead sponsor

Terumo Medical Corporation

Industry

Collaborators

  • Medical University of South Carolina

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2015
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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