|- candidate number||10157|
|- NTR Number||NTR2988|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2011|
|- Secondary IDs||NL34961.044.10 / P10-50 CCMO / MEC|
|- Public Title||Validation of Medimate MiniLab, lithium lab-chip.|
|- Scientific Title||Validation of Medimate MiniLab with lithium lab-chip.|
|- hypothesis||Show accurate and proper functioning of the Medimate MiniLab system for professional and self test use.The objective of the studies is to show the performance of 10% or 0.1 mmmol/l @ 95% confidence interval.|
|- Healt Condition(s) or Problem(s) studied||Lithium, Bipolar disorder, Correlation, Self test|
|- Inclusion criteria||Bipolar patients > 18 years, using lithium and treated and selected by psychiatrists (clinic or outpatient) of MST Enschede or other medical centers.|
|- Exclusion criteria||1. Non-lithium users;|
2. Not able to read or write dutch.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-aug-2011|
|- planned closingdate||31-dec-2012|
|- Target number of participants||94|
|- Interventions||Correlation study between standard validated laboratory equipment for lithium and the Medimate MiniLab. The lithium results of whole blood finger prick sample measured on the Medimate device are to be compared to the results of venous blood sample on the laboratory equipment. Both samples will be taken at the same instant.|
The research will consists of three different phases, to be carried out after each other.
Phase 1: Show correlation between golden standard and Medimate system within artificial laboratorial setting based on precision and proven equivalence.
Phase 2: Validation of the system within daily clinical setting by laboratory professionals by method comparison based on accuracy.
Phase 3: Validation of the system in use by lay persons; physicians and patients.
|- Primary outcome||From the measurements the correlation between the measurement systems, the accuracy and liability are calculated and analyzed using Bland & Altman statistics and CLSI EP-9 Method Comparison. Precision analysis is done by standard deviation on residual, equivalence is shown by Anova analysis.|
|- Secondary outcome||Information on user friendlyness of the Medimate Minilab system.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Marian Tellegen|
|- CONTACT for SCIENTIFIC QUERIES|| Steven Staal|
|- Sponsor/Initiator ||Medisch Spectrum Twente, Medimate BV|
(Source(s) of Monetary or Material Support)
|GO and EFRO funding the NIRION project, Medimate BV|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||14-jul-2011 - 26-jul-2011|