AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China

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.

NCT Number	NCT07208877
Lead Sponsor	Radiometer Medical ApS
Conditions	Diagnostic Tests
Enrollment	120 participants
Start Date	2025-10
Primary Completion	2025-10 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-06