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NCT04371159 · ClinicalTrials.gov registry record · NA
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
A NA study, sponsored by Healthy.io.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT04371159 is a NA study that has completed, run by Healthy.io. The registered enrollment target is 125 participants.
The verdict
NCT04371159, a NA study, has completed, sponsored by Healthy.io.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
Study Summary
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
Interventions
- DEVICE Velieve U.S.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2020-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04371159
The ClinicalTrials.gov registry entry for NCT04371159 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Healthy.io, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Velieve U.S. is the first listed.
NCT04371159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04371159 about?
NCT04371159 is a clinical study titled "A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System". The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,inc...
What is the current status of trial NCT04371159?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2020-02-05. Estimated completion is 2020-05-30.
What interventions are being tested in trial NCT04371159?
The interventions under investigation include: Velieve U.S. (DEVICE).
Who is sponsoring clinical trial NCT04371159?
This trial is sponsored by Healthy.io, which has 7 total clinical trials registered on ClinicalTrials.gov.
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