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

Not Applicable

Recruiting

• Conditions: Potassium Measurement

• Registration Number: NCT05975632
• Lead Sponsor: CardioRenal

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 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 Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study Start: 2023-08-02
• Study First Posted: 2023-08-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-02
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Calibrations factors and correlations R²	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)	through study completion, an average of 3 months	potassium values

Secondary Outcome Measures

Name	Time	Method
Determination of mean, standard deviation (SD) and coefficient of variation (CV)	through study completion, an average of 3 months	repeatability
Usability Evaluation questionnaire	through study completion, an average of 3 months

Trial Locations

Locations (6)

Centre d'Investigation Clinique; 🇫🇷 Grenoble, France

CHU Grenoble-Alpes; 🇫🇷 Grenoble, France

Agduc La Tronche; 🇫🇷 La Tronche, France

Diaverum; 🇫🇷 Marseille, France

Hôpital Saint Joseph; 🇫🇷 Marseille, France

Biogroup; 🇫🇷 Meylan, France