CAVE
Research type
Research Study
Full title
CApillary VEnous paired collection
IRAS ID
353441
Contact name
Orod Osanlou
Contact email
Sponsor organisation
Entia Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
024-120, IRB
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick.
Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line, especially around counts of interest.
A version of the Entia Liberty device has been UKCA approved and Entia is now collecting more evidence to submit its FDA 510K application. The devices used in this study will be slightly modified (in its display - the User Interface) from the version of the device that is UKCA approved.
All participants are asked to do 3 finger prick tests on the Liberty device themselves and they will be observed by a researcher. After they have done their 3 finger prick tests, they will have their routine venous blood drawn and tested on the laboratory analyser per routine care. One of the sites involved will have an additional bottle of venous blood taken from participants and the researchers at the site will test the venous blood on Liberty.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0092
Date of REC Opinion
29 May 2025
REC opinion
Favourable Opinion