Poor Peripheral PerfusionNCT02478671
Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied
A study testing TR Band in people with Poor Peripheral Perfusion, run by Terumo Medical Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poor Peripheral Perfusion
- What is being tested?
- TR Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Abnormal result of either baseline Barbeau or reverse Barbeau tests.
- Pregnant or breast feeding female.
- Subject with contraindication to MRI
About this study
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.
Read the 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.
- Conditions
- Poor Peripheral Perfusion
- Being tested
- TR Band
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR BandDevice
The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TR Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Based Radial Artery Measurement
Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.
Measured: Subjects will be followed up to one week post procedure
Secondary outcomes (1)
Hand Perfusion as Measured by Pulse Oxymetry Waveform
pulse oxymetry waveform will be used to measure arterial perfusion
Measured: Subjects will be followed up to one week post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Poor Peripheral PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Marcelo Guimaraes, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478671
- Sponsor's protocol ID
- TIS2015-002
- Status last verified
- Feb 2016
- First submitted
- 19 May 2015
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied
- ClinicalTrials.gov ID
- NCT02478671
- Acronym / sponsor ID
- TIS2015-002
- Conditions
- Poor Peripheral Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Terumo Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TR Band | Experimental | Device: TR BandEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Abnormal result of either baseline Barbeau or reverse Barbeau tests.
- Pregnant or breast feeding female.
- Subject with contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR BandThe radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured | Device | TR Band |
Primary outcome
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.
1 secondary outcome
Hand Perfusion as Measured by Pulse Oxymetry Waveform
Time frame: Subjects will be followed up to one week post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Poor Peripheral Perfusion
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A Single-center, Randomized, Double-blind, Placebo-controlled, Intervention Clinical Trial to Evaluate the Efficacy and Safety of "KoreaGinseng F Max" on Blood Circulation Improvement in Adults With Poor Peripheral Blood Flow
Blood Circulation, Peripheral Blood Flow
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Guimaraes, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing TR Band in people with Poor Peripheral Perfusion, run by Terumo Medical Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Based Radial Artery Measurement (time frame: Subjects will be followed up to one week post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.