Entia Liberty: Usability Validation
Research type
Research Study
Full title
Entia Liberty: Usability Validation
IRAS ID
304701
Contact name
Madeline Lok
Contact email
Sponsor organisation
Entia
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 28 days
Research summary
Entia is producing a home-monitoring solution for cancer patients that measures haemoglobin (Hb) total white blood cell count (WBC), Neutrophil count (ANC) and Platelet count (PLT).
This study will aim to evaluate the usability (how easy is it for patients to use) of the Entia Liberty device. Patients will be recruited and invited to participate in a remote training session at an agreed time between themselves and a member of the Entia team. This session will be held at the hospital. At the beginning of the session, the participant will spend some time familiarising themselves with the device and its components and will have time to unbox it and to read through the instructions and set up guide. After this, they will join a video call with the Entia team member providing the training where they will be able to ask any questions and perform a finger prick test. This session will be set up and supervised by the HCP working on the study who has also been trained how to take finger prick samples and will be in a simulated home environment (as much as practical).
Materials provided to the participant will include the Instructions for Use (IFU) and Set Up Guide.
After the participant has completed a finger prick on themselves, the HCP will perform another finger prick test on the participant (on their other hand). A test with this blood sample will be run on another Liberty device. The results from the both tests will be recorded for comparison. Finally, the participant will complete a usability feedback questionnaire.
This study forms part of Entia’s regulatory submission by demonstrating the usability performance claims of the Entia Liberty device through clinical evidence and to demonstrate that at least 80% of users are able to use the device. The study will be used to simulate use of the Entia Liberty solution to demonstrate that the intended users can use the solution safely and effectively. The study will assess that the user is able to perform a test, within a difference in result no greater than 15% and 35% for the parameters of haemoglobin and neutrophils respectively, compared to the results obtained from the health care professional.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0718
Date of REC Opinion
12 Nov 2021
REC opinion
Further Information Favourable Opinion