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NOT YET RECRUITING
NCT07208877
AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
Sponsor: Radiometer Medical ApS
View on ClinicalTrials.gov
Summary
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
Official title: NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-10
Completion Date
2026-01
Last Updated
2025-10-06
Healthy Volunteers
Not specified