The main objective is to define the self-test performance by means of the Total Error for the Medimate Minilab 2017 for the set of parameters.
ID
Source
Brief title
Condition
- Other condition
- Electrolyte and fluid balance conditions
- Manic and bipolar mood disorders and disturbances
Synonym
Health condition
zelftest diagnostiek bij verschillende patient populaties en medicate controle, patienten met totale parenterale voeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Estimation of the Total Error of different self test parameters including an
evaluation of the self test capability.
Secondary outcome
n.a.
Background summary
CE-Mate BV, with trade name Medimate, has developed a self-test for blood and
urine parameters based on microchip electrophoresis. The Medimate Minilab 2017
release of the self-test needs to be validated for different parameters that
can be measured at once.
Study objective
The main objective is to define the self-test performance by means of the Total
Error for the Medimate Minilab 2017 for the set of parameters.
Study design
The study design is based on method comparison, precision and interference
evaluations in combination with a lay user questionnaire.
Study burden and risks
Patient need to travel and venous and finger stick samples are taken for the
study.
No direct benefit. Benefit on long term possible by improved therapy.
No health risks are identified other then the standard risks identified with
venous and finger stick sampling.
De Veldmaat 10
Enschede 7522NM
NL
De Veldmaat 10
Enschede 7522NM
NL
Listed location countries
Age
Inclusion criteria
1. > 18 years;
2. The participant has to be able to speak and read Dutch;
3. Healthy volunteers
4. The participant has to be part of the targeted patient group
Exclusion criteria
Under 18, no speaking and writing capabilities in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62392.044.17 |
| Other | nog niet bekend |