Vascular Access ComplicationNCT02200458
Near-infrared Software Performance Study
A study testing VeinViewer in people with Vascular Access Complication, run by Christie Medical Holdings, Inc. at 1 site in United States.
Trial summary
This study will look at the performance capabilities of software for VeinViewer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- VeinViewer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2014
- 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
- Must be 18 years of age or older
- Must be considered to be in overall good health by investigator
- Must pass all prescreening questions
- Must be able to read and understand English
Who cannot join
- Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.
- IV cannulation in the arms or hands in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christie Medical Holdings, Inc.
Memphis, Tennessee, 38104
About this study
Official title: Near-Infrared Software Performance Study
This study will look at the performance capabilities of software for VeinViewer.
Read the detailed description
This study will look at the performance capabilities of future software for VeinViewer.
- Conditions
- Vascular Access Complication
- Being tested
- VeinViewer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinViewerDevice
Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.
| Study group | Role | What they receive |
|---|---|---|
| VeinViewer | Experimental | Vascular imaging technology will be used to visualize peripheral vasculature. Receives: Device: VeinViewer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for Whom Successful Visualization of Vasculature Was Achieved
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2014
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 Vascular Access ComplicationStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Schears, MD, Principal investigator, Christie Medical Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200458
- Sponsor's protocol ID
- CP1019
- Status last verified
- Mar 2015
- First submitted
- 21 Jul 2014
- Last updated
- 9 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Software Performance Study
- ClinicalTrials.gov ID
- NCT02200458
- Acronym / sponsor ID
- CP1019
- Conditions
- Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the performance capabilities of software for VeinViewer.
Detailed description
This study will look at the performance capabilities of future software for VeinViewer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VeinViewer | Experimental | Device: VeinViewerVascular imaging technology will be used to visualize peripheral vasculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18 years of age or older
- Must be considered to be in overall good health by investigator
- Must pass all prescreening questions
- Must be able to read and understand English
Key exclusion criteria (2 listed)
- Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.
- IV cannulation in the arms or hands in the previous 4 weeks.
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 |
|---|---|---|
| VeinViewerUpdated software on the VeinViewer device will be used to project an image of the vasculature on the skin. | Device | VeinViewer |
Primary outcome
Number of Participants for Whom Successful Visualization of Vasculature Was Achieved
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory Schears, MD 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?
A study testing VeinViewer in people with Vascular Access Complication, run by Christie Medical Holdings, Inc. at 1 site in United States.
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 4 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 9 Mar 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2015). 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?
Number of Participants for Whom Successful Visualization of Vasculature Was Achieved (time frame: One day). 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 9 Mar 2015.