Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
Study NCT ID:
NCT04371159
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2020-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Sponsor:
Healthy.io Ltd.
Organization:
Study Overview
Official Title:
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. 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 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.
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.
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?: