CE Mark Home Self-Test finger blood Total WBC, HGB, GRN, + Temperature
Research type
Research Study
Full title
PROTOCOL FOR THE COMMERCIAL STUDY TO ENABLE CE MARKING FOR THE SALE OF A WBC, GRN AND Hb MEASURING DEVICE AND EAR-THERMOMETER WITH TELEHUB, WITHIN THE EU.
IRAS ID
142816
Contact name
David D'Cruz
Contact email
Sponsor organisation
Philips Healthcare Incubator(Home Clinical Monitoring), Eindhoven, The Netherlands
ISRCTN Number
ISRCTN71085103
Research summary
Commercial study to obtain CE marking for sale of device into the UK. The Minicare H-2000 is a self-test system designed for a patient to home-test their total white cell blood count, granulocyte cell blood count and haemoglobin value. Results are automatically sent to Hospital Server. The granulocyte count provides an indication of the neutrophil level in patients blood, giving an indication of how blood cell levels are dropping during chemotherapy, and the recovery of blood cell count leading to the next course of chemotherapy. Currently there is no monitoring of blood count in patients during each chemotherapy cycle (eg. Breast Cancer 21 day cycles). Severe neutropenia leads to urgent A&E admission. The study is designed to check the performance of the device across the cell count and haemoglobin concentration range. There is no intention to profile chemotherapy patients during the study, only to show that laypersons can self-test finger blood for accurate cell count and haemoglobin values across the performance range. Study assesses training and visual aids (literature, videos) available with the “for sale“ home-test system. 150 patients (adults, from any hospital department but not having leukaemia) will perform finger-blood and ear-temperature testing within 1 week at the hospital (3 clinic sites) monitored by professional staff to see if any issues with performing the test properly. Following this, 30 patients will have devices installed in their homes and will test QC material over a 4 week period plus take their temperature and answer some health assessment questions. This will additionally determine that patients can effectively use the device in the home and that data is effectively transferred to a remote server (via a home-based tablet/telehub). Patients will be asked within both parts of the study, to complete a questionnaire involving the ease of use of the Minicare H-2000 system.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0021
Date of REC Opinion
3 Mar 2014
REC opinion
Further Information Favourable Opinion