Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053788
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-09-06
Brief Title:
PocDoc Lipids Usability Study for Self-test Use
Sponsor:
Vital Signs Solutions Ltd
Organization:
Vital Signs Solutions Ltd
Study Overview
Official Title:
PocDoc Lipids Usability Study for Self-test Use
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This study seeks to expand the approved indication of use for a UKCA approved IVD device PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples This study will investigate the usability of the device by untrained lay people in order to expand the devices utility to the self-test setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None