AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
NCT07208877 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120
Last updated 2025-10-06
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.
Conditions
- Diagnostic Tests
Sponsors & Collaborators
-
Radiometer Medical ApS
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2025-10-31
- Completion
- 2026-01-31
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