GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.

Conditions
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Potassium Measurement

Intervention / Treatment
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* Device: Device: Self testing Potassium device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for subjects not on dialysis: Male/female subject, aged 18+ years ; Signing a written informed consent ; Willing to perform the self-test after viewing the instruction for use; Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Inclusion Criteria for hemodialysis patients: Male/female subject, aged 18+ years ; Medical history of hyperkalemia ; Signing a written informed consent ; Willing to perform the self-test after viewing the instruction for use; Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Non-inclusion Criteria for subjects not on dialysis: Medical history of seizure (epilepsy) Known inherited hemolytic anemia Autoimmune hemolytic anemia Infectious Hemolytic anemia Prosthetic Cardiac valves Hemolytic uremic syndrome Peripheral edema Dehydration Peripheral Arterial Obstructive Disease (PAOD) Raynaud syndrome Known evolutive cancers Subjects who are pregnant or breast-feeding Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities > 6000 euros for a 12-months period) Non-inclusion Criteria for hemodialysis patients: Medical history of seizure (epilepsy) Known inherited hemolytic anemia Autoimmune hemolytic anemia Infectious Hemolytic anemia Prosthetic Cardiac valves Hemolytic uremic syndrome Peripheral edema Dehydration Peripheral Arterial Obstructive Disease (PAOD) Raynaud syndrome Known evolutive cancers Subjects who are pregnant or breast-feeding Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities > 6000 euros for a 12-months period)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potassium measurement<br>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 | Device: Device: Self testing Potassium device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-test, capillary collection, in-vitro diagnostic medical device