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

NCT05975632 | Unknown

• 1 other identifier: CR-2023-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Potassium Measurement

Keywords

self-test; capillary collection; in-vitro diagnostic medical device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Determination of mean, standard deviation (SD) and coefficient of variation (CV)

  through study completion, an average of 3 months

• Usability Evaluation questionnaire

  through study completion, an average of 3 months

Other Outcomes (1)

• Record and evaluate adverse events

  through study completion, an average of 3 months

Study Arms (1)

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

Device: Device: Self testing Potassium device

Interventions

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

Potassium measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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.
• Medical history of seizure (epilepsy)
• Known inherited hemolytic anemia
• Autoimmune hemolytic anemia
• Infectious Hemolytic anemia
• Prosthetic Cardiac valves
• Hemolytic uremic syndrome

Sponsors & Collaborators

• CardioRenal: lead

Study Sites (6)

Centre d'Investigation Clinique

Grenoble, France

RECRUITING

CHU Grenoble-Alpes

Grenoble, France

RECRUITING

Agduc La Tronche

La Tronche, France

RECRUITING

Diaverum

Marseille, France

NOT YET RECRUITING

Hôpital Saint Joseph

Marseille, France

NOT YET RECRUITING

Biogroup

Meylan, France

RECRUITING

Study Officials

• Pierre-Louis Carron, MD

  CHU Grenoble-Alpes Service de Nephrologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurice BERENGER, PhD

CONTACT

+33613903869; support@cardio-renal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 2, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

FR (6)