MedTrace Logo

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

NCT05975632 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-01-23

No results posted yet for this study

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

Interventions

DEVICE

Device: Self testing Potassium 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

Sponsors & Collaborators

  • CardioRenal

    lead INDUSTRY

Principal Investigators

  • Pierre-Louis Carron, MD · CHU Grenoble-Alpes Service de Nephrologie

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2024-02-29
Completion
2024-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975632 on ClinicalTrials.gov