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.

Study Overview

• Status: Completed
• Conditions: Poor Peripheral Perfusion
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Female or male adult (has reached the legal majority age).
2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.

Exclusion Criteria:

1. Abnormal result of either baseline Barbeau or reverse Barbeau tests.
2. Pregnant or breast feeding female.
3. Subject with contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: TR Band; The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Collaborators: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: TIS2015-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No