Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT05975632
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
Sponsor:
CardioRenal
Organization:
Study Overview
Official Title:
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: