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

Poor Peripheral Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02478671
• Other study ID #: TIS2015-002
• Status: Not yet recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: June 24, 2015
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: June 2015
• Source: Terumo Medical Corporation
• Contact: Jodie A Ruffing, ADN, BSBA
• Email: jodie.ruffing[@]terumomedical.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Subjects' radial artery diameters and plethsmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

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 oxymetery, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Poor Peripheral Perfusion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Terumo Medical Corporation	Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery compression measured using MRI	measure degree of artery compression while TR Band is in place	Subjects will be followed up to one week post procedure	No
Secondary	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	No