NCT06693050

Brief Summary

The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2024

Last Update Submit

July 2, 2025

Conditions

Diagnostic Test

Outcome Measures

Primary Outcomes (1)

  • Slope, R

    Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites

    5 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

You may qualify if:

  • 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 assay.

You may not qualify if:

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  • Subject, who has withdrawn consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospiltal Universitari Germans Trias i Pujol

Badalona, Spain

Location

Clinica Universidad de Navarra

Madrid, Spain

Location

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

Ùbeda, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 18, 2024

Study Start

December 9, 2024

Primary Completion

June 11, 2025

Study Completion

June 11, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Locations

ES(3)