Potassium MeasurementNCT05975632
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
A study testing Device: Self testing Potassium device in people with Potassium Measurement, run by CardioRenal at 6 sites in France.
Trial summary
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potassium Measurement
- What is being tested?
- Device: Self testing Potassium device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Aug 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Male/female subject, aged 18+ years ;
- Medical history of dyskalemia ;
Show all 41Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Centre d'Investigation Clinique
Grenoble
- Recruiting
CHU Grenoble-Alpes
Grenoble
Pierre-Louis Carron, MD, +33 476 765 460, PLCarron@chu-grenoble.fr
- Recruiting
Agduc La Tronche
La Tronche
Philippe Zaoui
- Not yet recruiting
Diaverum
Marseille
Luc Frantzen, lfrantzen@hopital-saint-joseph.fr
- Not yet recruiting
Hôpital Saint Joseph
Marseille
Luc Frantzen, MD, lfrantzen@hopital-saint-joseph.fr
- Recruiting
Biogroup
Meylan
About this study
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
Read the 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 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.
- Conditions
- Potassium Measurement
- Being tested
- Device: Self testing Potassium device
- Keywords
- self-test, capillary collection, in-vitro diagnostic medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Self testing Potassium deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Device: Self testing Potassium device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calibrations factors and correlations R²
potassium values
Measured: 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
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
Determination of mean, standard deviation (SD) and coefficient of variation (CV)
repeatability
Measured: through study completion, an average of 3 months
Usability Evaluation questionnaire
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start2 Aug 2023
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potassium MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioRenal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre-Louis Carron, MD, Principal investigator, CHU Grenoble-Alpes Service de Nephrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975632
- Sponsor's protocol ID
- CR-2023-001
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
- ClinicalTrials.gov ID
- NCT05975632
- Acronym / sponsor ID
- CR-2023-001
- Conditions
- Potassium Measurement
- Keywords
- self-test, capillary collection, in-vitro diagnostic medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CardioRenalIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potassium measurement | Experimental | Device: Device: Self testing Potassium deviceCalibration 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- 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.
- Male/female subject, aged 18+ years ;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Self testing Potassium deviceCalibration 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 | Device | Potassium measurement |
Primary outcome
Calibrations factors and correlations R²
Time frame: through study completion, an average of 3 months
potassium values
Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry)
Time frame: through study completion, an average of 3 months
potassium values
2 secondary outcomes
Determination of mean, standard deviation (SD) and coefficient of variation (CV)
Time frame: through study completion, an average of 3 months
Usability Evaluation questionnaire
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Louis Carron, MD principal investigator
CHU Grenoble-Alpes Service de Nephrologie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Self testing Potassium device in people with Potassium Measurement, run by CardioRenal at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurice BERENGER, PhD (+33613903869, support@cardio-renal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calibrations factors and correlations R² (time frame: through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.