Condition category
Not Applicable
Date applied
29/11/2013
Date assigned
12/12/2013
Last edited
12/12/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is no home test system for self-test blood cell count and ear-temperature test in the home. This study aims to validate the use of a new system for this purpose.

What does the study involve?
The new system will measure total white blood cell count (WBC), Granulocyte cell count (GRN) and haemoglobin (HGB) within finger prick blood. The new system is based on proven technology, and this study will achieve CE marking (the declaration from the manufacturer that the device complies with EU regulations).

Who can participate?
Patients attending routine clinics at St Thomas’ Hospital, London, aged 18-85, male or female, of a range of educational backgrounds, who will be selected to provide a range of WBC, GRN and HGB values to help evaluate the accuracy performance of the new device.
The study involves assessment of the ability of patients to perform a self-test using finger prick blood and to obtain a correct result. Each patient will also be assessed for their ability to perform ear temperature measurement and complete a health assessment questionnaire. The ability of patients to correctly test before and after training will be determined. Patients will also use the system in the home and will complete a questionnaire regarding ease of use.

What are the possible benefits and risks of participating?
There are no benefits to patients participating. In the longer term, once that CE marking has been obtained, patients could benefit from using the device in the home if their doctors think it is useful to monitor their blood status at home. Risk involved in participating is no greater than the risks that people with diabetes are exposed to in terms of finger prick sampling (ie some possible bruising).

Where is the study run from?
St Thomas’ Hospital, London, UK.

When is the study starting and how long is it expected to run for?
The study is expected to run for 3-4 months.

Who is funding the study?
Philips Electronics [Philips Healthcare Incubator] are funding the project.

Who is the main contact?
Dr Martin Payne
martin.payne@philips.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof David D'Cruz

ORCID ID

Contact details

Louise Coote Lupus Unit
St Thomas' Hospital
Westminster Bridge
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HCM003.CT.042

Study information

Scientific title

Protocol for the commercial study to enable CE marking for the sale of a whole white blood cell count, granulocyte blood cell count, and haemoglobin-measuring device and ear thermometer with telehub, within the European Union

Acronym

Study hypothesis

This CE mark commercial study should prove that the change in intended use for existing device technology to measure total white blood cell count (WBC), granulocyte (GRN) and haemoglobin (HGB) levels from finger capillary blood in the home by self-test users, provides clinically acceptable performance, and that patients can additionally measure their ear temperature.

Ethics approval

London City-East, 04/12/2013, Ref: 14/LO/0021

Study design

Observational CE mark study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

This is CE mark trial to prove device suitability for intended use - no drug therapy, no patient specific state monitoring sought

Intervention

The purpose of the study is to provide evidence that after training patients are able to perform a finger prick and add a blood droplet to a cartridge for successful and accurate measurement of white blood cell count and haemoglobin level using a device that has been designed for self-test use, based on a laboratory device. Patients are also asked to perform an ear temperature measurement following training and complete a questionnaire.

Patients visiting the clinic perform finger prick/ear-temperature measurements over 4 days, with training after an unaided first attempt. They are monitored unaided for the subsequent three visits.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To prove the device can be CE marked for its intended use

Secondary outcome measures

No secondary outcome measures

Overall trial start date

17/02/2014

Overall trial end date

30/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients attending clinics within St Thomas' Hospital, London, UK
2. Aged 18 - 85

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Leukaemic patients

Recruitment start date

17/02/2014

Recruitment end date

30/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Louise Coote Lupus Unit
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Philips Healthcare Incubator (Home Clinical Monitoring) (Netherlands)

Sponsor details

Building 34
High Tech Campus
Eindhoven
5656AE
Netherlands

Sponsor type

Industry

Website

http://www.healthcare.philips.com/gb_en/

Funders

Funder type

Industry

Funder name

Philips Electronics (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes