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AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study

NCT ID: NCT06905392

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

Detailed Description

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Conditions

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Diagnostic Tests

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
* Subjects must be 18 years of age or older.
* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

Exclusion Criteria

* Subjects known to be pregnant or breast-feeding.
* Subjects previously enrolled in the study.
* Subject, who has withdrawn consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiometer Medical ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hennepin Healthcare (Research Institute/ Minneapolis Medical Research Foundation)

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Santiago Compostela

Santiago de Compostela, , Spain

Site Status RECRUITING

Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz

Ùbeda, , Spain

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Spain

Facility Contacts

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Hannah Brown, PhD

Role: primary

Karen Schulz

Role: backup

Estíbaliz Alegre Martínez, Dr.

Role: primary

Alvaro Gonzalez Hernandez, Dr.

Role: backup

Gonzalez

Role: primary

Other Identifiers

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DC-087459

Identifier Type: -

Identifier Source: org_study_id