Vascular AccessNCT01453322
Video Documentation of Localized Complications
An observational study of Vascular Access, run by Christie Medical Holdings, Inc. at 1 site in United States.
Trial summary
The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV… 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
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2011
- 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 adult volunteers
Who may be able to join
- Must be 18 years of age or older
- Must be considered in good health by investigator
- Must be able to read and understand English
Who cannot join
- Less than 18 years of age
- Known allergy to Heparin
- History of HIT (Heparin-induced thrombocytopenia)
- Unable to read and understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology
The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.
- Conditions
- Vascular Access
- Keywords
- Veins, Vascular Access, IV complications, VeinViewer Vision
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve and Refill Confirmation
Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.
Measured: Immediately after flush-Day 1
Secondary outcomes (1)
Video Documentation of localized vascular access complications
Using VeinViewer, the user will be able to detect hematomas and infiltrations.
Measured: Immediately after attempt-Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward P Scott, MD, Principal investigator, Key Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453322
- Sponsor's protocol ID
- CP1009
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology
- ClinicalTrials.gov ID
- NCT01453322
- Acronym / sponsor ID
- CP1009
- Conditions
- Vascular Access
- Keywords
- Veins, Vascular Access, IV complications, VeinViewer Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Oct 2011 (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 confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (3 listed)
- Must be 18 years of age or older
- Must be considered in good health by investigator
- Must be able to read and understand English
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Known allergy to Heparin
- History of HIT (Heparin-induced thrombocytopenia)
- Unable to read and understand English
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
Valve and Refill Confirmation
Time frame: Immediately after flush-Day 1
Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.
1 secondary outcome
Video Documentation of localized vascular access complications
Time frame: Immediately after attempt-Day 1
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 18 Oct 2011.
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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.
Edward P Scott, MD principal investigator
Key Biologics, LLC
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 Vascular Access, 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 3 inclusion and 4 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 18 Oct 2011. 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?
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?
Valve and Refill Confirmation (time frame: Immediately after flush-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 18 Oct 2011.