CaVeP-DC
Research type
Research Study
Full title
Capillary-Venous Paired Data Collection
IRAS ID
329382
Contact name
Hannah Rawlinson-Smith
Contact email
Sponsor organisation
Entia
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Entia is currently going through the process of obtaining regulatory approval for Liberty. However, Entia would like to further improve the measurement performance of the Liberty device. This study is an iterative data collection study to continuously assess the performance of the Entia Liberty device with cancer patients through each update. The device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine blood test (venous - from the arm), where a additional small portion of blood (through the same blood collection reservoir) will be collected in a vacutainer. After that, the participants will have 2 fingers pricked to obtain 2 capillary blood samples. The capillary blood samples and the additional venous blood sample will be analysed on Entia Liberty devices, and the participants' routine blood test will be analysed on the usual lab analyser (gold standard, CE marked analyser). The results from the 4 tests will be compared with each other to ensure that the measurement performance of the Liberty device is improving overtime.
REC name
Wales REC 2
REC reference
23/WA/0205
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion