CE mark study of a home self-test system for blood cell count and ear temperature

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71085103

Enrollment

150

Registered

2013-12-12

Start date

2014-02-17

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is CE mark trial to prove device suitability for intended use - no drug therapy, no patient specific state monitoring sought Not Applicable

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Leukaemic patients

Design outcomes

Primary

Measure	Time frame
To prove the device can be CE marked for its intended use	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026