VisionVFvalidationNCT01138228
Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?
An observational study of Vision, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. Read more about this study
- Who is it for?
- Ages 4 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Vision
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2010
- 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 4 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Ages 4 weeks and above Light skin Dark skin Normal weight Obese weight
- Inclusion Criteria: All subjects will be automatically enrolled on a walk-in basis.
- Exclusion Criteria: No walk-in subjects will be excluded from enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospitals
New York, New York, 10019
About this study
Official title: Validation of Vue Tek Digital Vein Viewing Device
VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:
- Primary Objective: To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
- Secondary Objective:
Read more
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Validation Ancillary Endpoints
- To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.
Read the detailed description
Validation methodology:
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.
- Conditions
- Vision
- Keywords
- intravenous cannulation, vein identification, vascular identification, vein cannulation
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 |
|---|---|---|
| Normal vision | This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision). | |
| Vein Imaging Device | This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
Measured: Immediate
Secondary outcomes (1)
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. Number of veins identified by normal vision is compared to number of veins identified with the device in a counter balanced design.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VisionStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vue Tek Scientific
- Investigators
- Franco Resta-Flarer, M.D., Principal investigator, St. Luke's Roosevelt Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138228
- Sponsor's protocol ID
- VF Validation
- Acronym
- VFvalidation
- Status last verified
- Feb 2010
- First submitted
- 3 Mar 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Vue Tek Digital Vein Viewing Device
- ClinicalTrials.gov ID
- NCT01138228
- Acronym / sponsor ID
- VFvalidation / VF Validation
- Conditions
- Vision
- Keywords
- intravenous cannulation, vein identification, vascular identification, vein cannulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Vue Tek Scientific
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Jun 2010 (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.
VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:
- Primary Objective: To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
- Secondary Objective:
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Validation Ancillary Endpoints
- To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.
Detailed description
Validation methodology:
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal vision | – | –This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision). |
| Vein Imaging Device | – | –This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision). |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ages 4 weeks and above Light skin Dark skin Normal weight Obese weight
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
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
Time frame: Immediate
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
1 secondary outcome
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Time frame: Immediate
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 7 Jun 2010.
Related trials for Vision
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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.
Franco Resta-Flarer, M.D. principal investigator
St. Luke's Roosevelt Hospitals
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 Vision, run by St. Luke's-Roosevelt Hospital Center 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?
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 7 Jun 2010. 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?
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye. (time frame: Immediate). 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 7 Jun 2010.