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Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
Objectives are to assess the quantitative accuracy in freshly collected whole capillary blood from patients and healthy volunteers and to evaluate user proficiency. In order to gather a wide range of K+ concentrations, the study will be conducted both on patients or healthy volunteers and on dialysis patients.
The study includes 2 phases (calibration phase and comparison phase) where blood samples (capillary and venous) will be collected.Blood is taken from the subject by trained specialist staff. During the comparison phase, the subjects will be equipped with CardioRenal device and trained to do the self-test.
A subject's participation in this study (both calibration and validation phase) will consist of two interventional visits for hemodialysis patients and three interventional visits for other subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium measurement | Experimental | Calibration Phase : 1 visit (duration 1 day) for subjects not on dialysis and hemodialysis patients Comparaison Phase : 1 visit (diration 1 day) for hemodialysis patients Comparaison Phase : 2 visits (diration 1 day) for subjects not on dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Self testing Potassium device | Device | Calibration Phase (1 visit) (Hemodialysis patients and subjects not on dialysis) Each patient will have one venous blood collection. Among them, one 30 patients one capillary sample is collected. In this phase, the HCP is the user of the device. Comparison Phase For subject not on dialysis (total 2 visits): Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test For Hemodialysis patients (total 1 visit) : Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test |
| Measure | Description | Time Frame |
|---|---|---|
| Calibrations factors and correlations R² | potassium values | through study completion, an average of 3 months |
| Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry) | potassium values | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of mean, standard deviation (SD) and coefficient of variation (CV) | repeatability | through study completion, an average of 3 months |
| Usability Evaluation questionnaire | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Record and evaluate adverse events | through study completion, an average of 3 months |
Inclusion Criteria for subjects not on dialysis:
Inclusion Criteria for hemodialysis patients:
Non-inclusion Criteria for subjects not on dialysis:
Non-inclusion Criteria for hemodialysis patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurice BERENGER, PhD | Contact | +33613903869 | support@cardio-renal.com |
| Name | Affiliation | Role |
|---|---|---|
| Pierre-Louis Carron, MD | CHU Grenoble-Alpes Service de Nephrologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique | Recruiting | Grenoble | France | |||
| CHU Grenoble-Alpes |
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| Recruiting |
| Grenoble |
| France |
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| Agduc La Tronche | Recruiting | La Tronche | France |
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| Diaverum | Not yet recruiting | Marseille | France |
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| Hôpital Saint Joseph | Not yet recruiting | Marseille | France |
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| Biogroup | Recruiting | Meylan | France |