AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study | NCT06693050

Studies
AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

NCT06693050

Sponsor

Radiometer Medical ApS

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

153Actual

Phase

Not provided

Conditions

Diagnostic Test

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2024Actual

Primary Completion Date

Jun 11, 2025Actual

Completion Date

Jun 11, 2025Actual

First Submitted Date

Nov 14, 2024

First Submission Date that Met QC Criteria

Nov 14, 2024

First Posted Date

Nov 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Slope, R	Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites	5 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 assay.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospiltal Universitari Germans Trias i Pujol		Badalona			Spain
Clinica Universidad de Navarra