VeinsNCT01453335
Percentage Venous Options in Pediatrics & Adults
An observational study of Veins, run by Christie Medical Holdings, Inc. at 1 site in United States.
Trial summary
VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Veins
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric \& Adult patients presenting at the Emergency Department that do not have an acute or critical medical illness or injury that required immediate evaluation and/or treatment.
Who may be able to join
- Age 17 years of age or younger,
- Intact skin, without rash,irritation, scarring, open abrasion or other injury in these sites.
- Parent or guardian is English speaking
- Pediatric patients 8 years older will be asked to provide assent
- Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.
- Age 18 years or older,
Show all 9Show fewer
- At least one intact upper extremity (intact from the base knuckle to the shoulder)
- Intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury in these sites.
- Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.
Who cannot join
- 18 years of age or older
- No intact upper extremities
- Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.
- Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.
- Adult arm:
- Younger than 18 years of age
Show all 11Show fewer
- No intact upper extremities
- The participant does not have intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury preventing appropriate evaluation of these sites.
- Non-English speaking participant.
- Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.
- Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
HASBRO Children's Hospital
Providence, Rhode Island, 02903
About this study
Official title: Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)
VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate.
- Conditions
- Veins
- Keywords
- Veins, Catheter Segments, Vascular Access, VeinViewer Vision
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation
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 posted17 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeinsStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce M Becker, MD, Principal investigator, Hasbro Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453335
- Sponsor's protocol ID
- CP1001
- Status last verified
- Dec 2011
- First submitted
- 23 Aug 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)
- ClinicalTrials.gov ID
- NCT01453335
- Acronym / sponsor ID
- CP1001
- Conditions
- Veins
- Keywords
- Veins, Catheter Segments, Vascular Access, VeinViewer Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 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.
VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric \& Adult patients presenting at the Emergency Department that do not have an acute or critical medical illness or injury that required immediate evaluation and/or treatment.
Key inclusion criteria (9 listed)
- Age 17 years of age or younger,
- Intact skin, without rash,irritation, scarring, open abrasion or other injury in these sites.
- Parent or guardian is English speaking
- Pediatric patients 8 years older will be asked to provide assent
- Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.
Key exclusion criteria (11 listed)
- 18 years of age or older
- No intact upper extremities
- Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.
- Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.
- Younger than 18 years of age
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
Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation
Time frame: Immediately after assessment-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 23 Dec 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.
Bruce M Becker, MD principal investigator
Hasbro Children's Hospital
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 Veins, 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 9 inclusion and 11 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 23 Dec 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?
Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation (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 23 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.