Status:
RECRUITING
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
Lead Sponsor:
CardioRenal
Conditions:
Potassium Measurement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
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 ...
Eligibility Criteria
Inclusion
- 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 dyskalemia ;
- 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) stage 4
- 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) stage 4
- 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)
Exclusion
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05975632
Start Date
August 2 2023
End Date
March 1 2024
Last Update
January 23 2024
Active Locations (6)
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1
Centre d'Investigation Clinique
Grenoble, France
2
CHU Grenoble-Alpes
Grenoble, France
3
Agduc La Tronche
La Tronche, France
4
Diaverum
Marseille, France