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Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.

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ClinicalTrials.gov Identifier: NCT03102944
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Philips Handheld Diagnostics

Brief Summary:

Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.

K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.


Condition or disease Intervention/treatment
Healthy Diagnostic Test: Minicare BNP

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : March 24, 2017
Actual Study Completion Date : March 24, 2017

Group/Cohort Intervention/treatment
healthy volunteers
no intervention, extra blood tube taken with blood donation at bloodbank and blood is tested on IVD away from patient.
Diagnostic Test: Minicare BNP
no real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer.




Primary Outcome Measures :
  1. Normal values for BNP for the Minicare BNP [ Time Frame: 4 weeks ]
    To determine normal values for BNP levels for the Minicare BNP using K2- EDTA venous whole blood and K2-EDTA plasma samples from healthy subjects.


Biospecimen Retention:   Samples Without DNA
Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for potential future analysis/ projects.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy volunteers
Criteria

Inclusion Criteria:

  • ≥18 years old
  • Willing and able to sign the informed consent form (ICF)

Exclusion Criteria:

  • Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.
  • Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102944


Locations
Netherlands
Philips EB Handheld Diagnostics
Eindhoven, Netherlands
Sponsors and Collaborators
Philips Handheld Diagnostics
Investigators
Study Chair: Diederick Keizer Clinical Affairs Manager

Responsible Party: Philips Handheld Diagnostics
ClinicalTrials.gov Identifier: NCT03102944     History of Changes
Other Study ID Numbers: HHDx-07998
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No