Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04371159
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2020-04-30
Brief Title:
A Comparative Controlled Study to Evaluate the Clinical Accuracy of the Velieve US UTI Urine Analysis Test System
Sponsor:
Healthyio Ltd
Organization:
Healthyio Ltd
Study Overview
Official Title:
A Comparative Controlled Study to Evaluate the Clinical Accuracy of the Velieve US UTI Urine Analysis Test System
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Velieve US UTI Urine Analysis Test System henceforth Velieve US 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 guidanceincluding 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 US device Following the usability test performed by the lay user the subjects urine sample will be tested by the professional user using the comparator device
The use of the Velieve US device will be evaluated for identified risks Additionally measurable usability criteria for specific critical steps will be evaluated
The use of the Velieve US device will be evaluated for identified risks Additionally measurable usability criteria for specific critical steps will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None