Vascular AccessNCT01638065
A Comprehensive Look at Vascular Access
An observational study of Vascular Access, run by Christie Medical Holdings, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Access
- Type of treatment
- Injection or infusion
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at a medical facility requiring IV access.
Who may be able to join
- Requires peripheral venous access
- Intact skin on areas of assessment
- Patient and/or parent or legal guardian is able to understand consent
Who cannot join
- No Intact skin
- Patient is under anesthesia during peripheral venous access
- Patient is not a suitable candidate, as determined by the discretion of the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Good Samaritan Hospital
Downers Grove, Illinois, 60515
LA County Hospital
Los Angeles, California, 90033
About this study
Official title: A Comprehensive Look at Vascular Access: Utilizing a Near Infrared Vein Visualization Device For Vascular Access Planning, Attempts, and Post Access
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.
- Conditions
- Vascular Access
- Keywords
- vein identification, vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Standard IV Access without device | |
| VeinViewer | IV access with VeinViewer device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be total number of attempts for successful cannulation.
Measured: 1 day
Secondary outcomes (1)
Amount of time for successful venous access
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies 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
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638065
- Sponsor's protocol ID
- CP1011
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2012
- 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
- A Comprehensive Look at Vascular Access: Utilizing a Near Infrared Vein Visualization Device For Vascular Access Planning, Attempts, and Post Access
- ClinicalTrials.gov ID
- NCT01638065
- Acronym / sponsor ID
- CP1011
- Conditions
- Vascular Access
- Keywords
- vein identification, vascular access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jul 2012 (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.
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | – | –Standard IV Access without device |
| VeinViewer | – | –IV access with VeinViewer device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at a medical facility requiring IV access.
Key inclusion criteria (3 listed)
- Requires peripheral venous access
- Intact skin on areas of assessment
- Patient and/or parent or legal guardian is able to understand consent
Key exclusion criteria (3 listed)
- No Intact skin
- Patient is under anesthesia during peripheral venous access
- Patient is not a suitable candidate, as determined by the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint will be total number of attempts for successful cannulation.
Time frame: 1 day
1 secondary outcome
Amount of time for successful venous access
Time frame: 1 day
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access, run by Christie Medical Holdings, Inc. at 2 sites 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 3 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 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 2 sites 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?
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?
The primary endpoint will be total number of attempts for successful cannulation. (time frame: 1 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 3 Feb 2014.