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NCT01138228 · ClinicalTrials.gov registry record
Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?
A clinical trial, sponsored by St. Luke's-Roosevelt Hospital Center.
- Completed
- Registry status
- 106
- Enrollment target
NCT01138228: Completed study, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT01138228 is a clinical trial that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 106 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138228 has completed, sponsored by St. Luke's-Roosevelt Hospital Center.
- COMPLETED
- Registry status
- 106 participants
- Enrollment target
Study 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. 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: 1. Primary Objective: To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye. 2. Secondary Objective: To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye. Validation Ancillary Endpoints 1\. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-02 |
What the finished NCT01138228 record still lists
NCT01138228 is an observational study that tracks outcomes without assigning an intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01138228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01138228 about?
NCT01138228 is a clinical study titled "Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?". 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...
What is the current status of trial NCT01138228?
This trial is currently completed. The enrollment target is 106 participants. The study started on 2010-02. Estimated completion is 2010-02.
Who is sponsoring clinical trial NCT01138228?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
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