Status:
NOT_YET_RECRUITING
AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
Lead Sponsor:
Radiometer Medical ApS
Conditions:
Diagnostic Tests
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Samples that meet all the following criteria will be eligible for enrollment:
- Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure.
- Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..
- The sample volume is adequate, no less than 2 mL of whole blood.
- The sample collection shall meet the informed consent waiver requirements of the ethics committee.
Exclusion
- Samples that meet any of the following criteria will be excluded:
- Duplicate collection of samples from the same subject.
- Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.
- Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07208877
Start Date
October 1 2025
End Date
January 1 2026
Last Update
October 6 2025
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