Vein WidthNCT01807507
Clinical Verification Evaluation of VeinViewer® Device
An observational study of Vein Width, run by Christie Medical Holdings, Inc. at 1 site in Canada.
Trial summary
Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vein Width
- What is being tested?
- VeinViewer
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Healthy Volunteers
Who may be able to join
- Must be 18 years of age or older
- Must be able to read and understand English to understand the consent letter
Who cannot join
- Less than 18 years of age
- Unable to read and understand English to understand the consent letter
Trial locations and contacts
1 site in 1 country.
About this study
Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard
- Conditions
- Vein Width
- Being tested
- VeinViewer
- Keywords
- Veins, Vascular Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinViewerDevice
VeinViewer® is designed to improve vascular access treatment standards and provide the highest possible quality in volunteer care. The device is a non-invasive handheld electronic visual aid device designed to project an image of superficial, subcutaneous vascular structures on the surface of the skin. VeinViewer's primary purpose is to assist in vascular visualization for IV starts and blood draws.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Not described Receives: Device: VeinViewer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device validation versus ultrasound
The focus of this study is to understand the clinical effectiveness of the device.
Measured: Immediately after assessment-Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vein WidthStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Wagner, MS, Principal investigator, Christie Medical Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807507
- Sponsor's protocol ID
- CP1016
- Status last verified
- Jan 2014
- First submitted
- 6 Mar 2013
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Verification Evaluation of VeinViewer® Device
- ClinicalTrials.gov ID
- NCT01807507
- Acronym / sponsor ID
- CP1016
- Conditions
- Vein Width
- Keywords
- Veins, Vascular Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: VeinViewer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (2 listed)
- Must be 18 years of age or older
- Must be able to read and understand English to understand the consent letter
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Unable to read and understand English to understand the consent letter
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 |
|---|---|---|
| VeinViewerVeinViewer® is designed to improve vascular access treatment standards and provide the highest possible quality in volunteer care. The device is a non-invasive handheld electronic visual aid device designed to project an image of superficial, subcutaneous vascular structures on the surface of the skin. VeinViewer's primary purpose is to assist in vascular visualization for IV starts and blood draws. | Device | Healthy Volunteers |
Primary outcome
Device validation versus ultrasound
Time frame: Immediately after assessment-Day 1
The focus of this study is to understand the clinical effectiveness of the device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
Related trials for Vein Width
Not yet recruitingObservational study
Early Platelet Indices as Biomarkers of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated ICU Patients
Platelet Distribution Width, Mean Platelet Volume
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.
Ben Wagner, MS principal investigator
Christie Medical Holdings, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vein Width, run by Christie Medical Holdings, Inc. at 1 site in Canada.
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 2 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device validation versus ultrasound (time frame: Immediately after assessment-Day 1). 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 3 Feb 2014.