Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT05975632
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05975632
Study Brief:
Protocol Section:
NCT05975632