|- candidate number||28165|
|- NTR Number||NTR6806|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2017|
|- Secondary IDs||NL62392.044.17 Medisch Ethische Toetsingscommissie Twente|
|- Public Title||Validation Reseach of Medimate Minilab, Multi Lab-chip 2017|
|- Scientific Title||Validation Reseach of Medimate Minilab, Multi Lab-chip 2017|
|- hypothesis||To validate the Total Error of the Medimate Minilab for Sodium, Potassium,Lithium and Creatinine analysis in blood and for Sodium, Potassium, Creatinine and Magnesium analysis in Urine|
|- Healt Condition(s) or Problem(s) studied||Parenteral nutrition, Manic depressive illness|
|- 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||1. Under 18|
2. No speaking and writing capabilities in Dutch
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-nov-2017|
|- planned closingdate||31-dec-2022|
|- Target number of participants||1185|
|- Interventions||Validation of a selftest in finger prick whole blood, venous whole blood, plasma and urine. |
|- Primary outcome||The primary result will be a validated Medimate Minilab 2017 with a defined Total Error in mmol/l with a confidence interval of 95%..|
|- Secondary outcome||Specific validation results per patient group.|
Interference test results.
Selftest performance results.
Method Comparison results.
Limit of quantification results.
|- Timepoints||not applicable|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Steven Staal|
|- CONTACT for SCIENTIFIC QUERIES|| Steven Staal|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, CE-Mate BV, Diagnostiek voor U|
(Source(s) of Monetary or Material Support)
|- Publications||Staal, S. et al., A versatile electrophoresis-based self-test platform.|
ELECTROPHORESIS, 2015, 36: 712–721. doi: 10.1002/elps.201400428
|- Brief summary||This study is to validate the Total Error of the Medimate Minilab for Sodium, Potassium, Lithium and Creatinine analysis in blood and for Sodium, Potassium, Creatinine and Magnesium analysis in Urine|
These validation studies will provide statistical information concerning the accuracy, precision and reliability of the measurement under varying circumstances.
During this validation study the precision, accuracy and reliability are validated for the different parameters. These evaluations are designed to prove the Minilab 2017 performance under normal and extreme conditions.
|- Main changes (audit trail)|
|- RECORD||8-nov-2017 - 30-nov-2017|