HealthyNCT05186311

BD MiniDraw™ Capillary System Clinical Equivalence Study

A study testing Capillary Blood Collection System in people with Healthy and Disease, Chronic, run by Becton, Dickinson and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy, Disease, Chronic, Acute Disease
What is being tested?: Capillary Blood Collection System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 262 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2022to 24 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants ≥18 years of age.
Not currently pregnant (self-reported)
Adequate access to four fingers (ring and middle finger on each hand) and inner elbows for blood collection procedures
Willing and able to comply with all study procedures and evaluations
Ability to read, write, and understand English language
Provision of signed and dated informed consent form

Who cannot join

Evidence of skin issues such as infections, ulcerations, blisters, peripheral vascular disease, inflammation, extensive scarring or calluses, or healed burns at the fingerstick site. Subject to post-study exclusion period for this or other related studies:
A study participant may enroll once in study part A and once in study part B of this clinical study. They may not enroll more than once in a single study part.
If a study participant has previously enrolled in one study part and would like to enroll in the second study part, they must wait 8 days from the time of the first study part collection procedures to enroll in the second study part collection procedures.
Any condition which, in the opinion of the Investigator, would preclude participation in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Babson Diagnostics
Austin, Texas, 78753

Other trials in United States

About this study

Official title: A Prospective Multi-center Study to Evaluate Clinical Equivalence (Method Comparison) Between the BD MiniDraw™ SST™ Capillary Blood Collection Tube and BD MiniDraw™ EDTA Capillary Blood Collection Tube to Respective Comparators

This study designed to evaluate the safety and effectiveness of a newly developed sample collection device. Participants will be enrolled and samples will be collected by representative future users of the device. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be tested and average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations will be captured and device safety will be assessed.

Read the detailed description

The current method for collection of a large volume of capillary blood (up to 600 µL) involves optional warming of the hand or finger prior to procedure, lancing of the fingertip, squeezing the fingertip by hand, and dripping the blood into an open non-sterile tube. The capillary blood collection process is considered cumbersome and lacks standardization in how much pressure is applied in squeezing of the finger which may lead to poor sample quality or insufficient blood volume. Common sample quality issues for capillary blood collection include hemolysis and dilution of sample with interstitial fluid, potentially causing bias in test results. Open collection also carries a risk of blood exposure for healthcare workers and potential risk of infection at the finger puncture site. A new device, BD Microtainer® Easy Collect Capillary Blood Collection System for the collection of capillary blood was created to standardize the current collection process and improve sample quality.

This study designed to evaluate the safety and effectiveness of the BD Microtainer® Easy Collect Capillary Tube SST™ and BD Microtainer® Easy Collect Capillary Tube EDTA devices. This study will be conducted in two parts, one for the SST product and the other for the EDTA product. A minimum of 100 participants, and a maximum of 150 participants per part will be enrolled at a minimum of three various ancillary healthcare site settings representative of the intended use environment such as retail pharmacy site, patient service center, and/or urgent care clinic. Samples will be collected by representative future users of the BD Microtainer® Easy Collect Capillary Blood Collection System who may not have prior blood collection experience. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be collected, clotted (serum samples only) and centrifuged (serum samples only) before transportation to the laboratory where they will be tested.

Average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations for the SST products will be captured which include hemolysis as measured by Plasma Free Hemoglobin (PFH); collection volume; and duration of sample collection. Visual Observations for the EDTA products will be captured which include frequency of occurrence of instrument flags; frequency of occurrence of platelet clump instrument flags; frequency of instrument platelet clump flags with no platelet clump; evaluate whole blood collection volume; and duration of sample collection. Lastly, device safety will be assessed by device and procedure related adverse events.

Conditions: Healthy, Disease, Chronic, Acute Disease, Sample Collection
Being tested: Capillary Blood Collection System
Keywords: sample collection device
Medical subject headings: Chronic Disease, Acute Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capillary Blood Collection SystemDevice
Also called BD MiniDraw™ Capillary System
Test Blood Sample Collection

Study groups in NCT05186311
Study group	Role	What they receive
Test product	Experimental	BD MiniDraw™ Capillary Blood Collection System Receives: Device: Capillary Blood Collection System

What is being measured

The primary outcome is the main question the study is designed to answer.

Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL
Measured: within 4 hours of sample collection
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators venous comparator and capillary comparator. This comparison was focused on the analytes with a unit of percentage
Measured: within 2 hours of sample collection
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of µIU/mL
Measured: within 4 hours of sample collection
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mg/dL
Measured: within 4 hours of sample collection
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mmol/L
Measured: within 4 hours of sample collection
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of ng/mL
Measured: within 4 hours of sample collection
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of U/L
Measured: within 4 hours of sample collection
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^3/µL
Measured: within 2 hours of sample collection
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^6/µL
Measured: within 2 hours of sample collection
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of fL
Measured: within 2 hours of sample collection
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of g/dL
Measured: within 2 hours of sample collection
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of pg
Measured: within 2 hours of sample collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202224 Oct 2022

First posted11 Jan 2022
Study start22 Apr 2022
Primary completion24 Oct 2022
Study completion24 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05186311
Sponsor's protocol ID: PAS-21YODA005
Status last verified: Oct 2023
First submitted: 17 Dec 2021
Last updated: 3 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multi-center Study to Evaluate Clinical Equivalence (Method Comparison) Between the BD MiniDraw™ SST™ Capillary Blood Collection Tube and BD MiniDraw™ EDTA Capillary Blood Collection Tube to Respective Comparators
ClinicalTrials.gov ID: NCT05186311
Acronym / sponsor ID: PAS-21YODA005
Conditions: Healthy, Disease, Chronic, Acute Disease, Sample Collection
Keywords: sample collection device
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
Collaborators: Babson Diagnostics
Study start: 22 Apr 2022 (actual)
Primary completion: 24 Oct 2022 (actual)
Study completion: 24 Oct 2022 (actual)
First posted: 11 Jan 2022 (actual)
Results: Posted 21 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test product	Experimental	Device: Capillary Blood Collection SystemBD MiniDraw™ Capillary Blood Collection System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants ≥18 years of age.
Not currently pregnant (self-reported)
Adequate access to four fingers (ring and middle finger on each hand) and inner elbows for blood collection procedures
Willing and able to comply with all study procedures and evaluations
Ability to read, write, and understand English language

Key exclusion criteria (4 listed)

Evidence of skin issues such as infections, ulcerations, blisters, peripheral vascular disease, inflammation, extensive scarring or calluses, or healed burns at the fingerstick site. Subject to post-study exclusion period for this or other related studies:
Any condition which, in the opinion of the Investigator, would preclude participation in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capillary Blood Collection SystemAlso: BD MiniDraw™ Capillary SystemTest Blood Sample Collection	Device	Test product

Primary outcome

Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL
White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators venous comparator and capillary comparator. This comparison was focused on the analytes with a unit of percentage
Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of µIU/mL
Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mg/dL
Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mmol/L
Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of ng/mL
Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples
Time frame: within 4 hours of sample collection
To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of U/L
White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^3/µL
Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^6/µL
Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of fL
Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of g/dL
Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)
Time frame: within 2 hours of sample collection
To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of pg

Results and safety

Results posted to the registry on 21 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	136	135

Primary outcome: Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples

Time frame: within 4 hours of sample collection. Mean (Full Range). Unit: g/dL

Measure	Test Product n = 100
ALB Test Device SST™	3.746 (1.01 to 5.54)
ALB Capillary Comparator SST™	3.787 (1.01 to 5.58)
TP Test Device SST™	6.77 (2.6 to 10.2)
TP Capillary Comparator SST™	6.83 (2.7 to 10.2)
ALB Venous comparator Serum	3.791 (1.00 to 5.44)
TP Venous comparator Serum	6.78 (2.6 to 9.8)

Population analysed: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.

Primary outcome: White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA)

Time frame: within 2 hours of sample collection. Mean (Full Range). Unit: % of analyte in the sample

Measure	Test Product n = 126
Basophils (BA)% Test Device EDTA	0.73 (0.0 to 2.0)
BA% Capillary Comparator EDTA	0.71 (0.0 to 1.9)
BA% Venous comparator EDTA	0.71 (0.0 to 1.8)
Eosinophils (EO)% Capillary Comparator EDTA	2.97 (0.0 to 12.0)
EO% Venous comparator EDTA	3.16 (0.0 to 16.0)
EO% Test Device EDTA	2.89 (0.0 to 10.7)
hemoglobin A1c (HbA1c) Capillary Comparator EDTA	5.938 (4.20 to 14.20)
HbA1c Venous comparator EDTA	5.965 (4.60 to 14.10)

Population analysed: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.

Primary outcome: Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples

Time frame: within 4 hours of sample collection. Mean (Full Range). Unit: µIU/mL

Measure	Test Product n = 94
TSH Test Device SST™	4.7599 (0.183 to 97.892)
TSH Capillary Comparator SST™	5.4529 (0.181 to 104.351)
TSH Venous comparator Serum	5.4211 (0.188 to 101.313)

Population analysed: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.

Primary outcome: Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples

Time frame: within 4 hours of sample collection. Mean (Full Range). Unit: mg/dL

Measure	Test Product n = 102
blood urea nitrogen (BUN) Test Device SST™	21.9 (8 to 115)
BUN Capillary Comparator SST™	22 (7 to 115)
Calcium (Ca) Test Device SST™	9.43 (2.7 to 13.6)
Ca Capillary Comparator SST™	9.52 (2.7 to 13.5)
cholesterol (Chol) Test Device SST™	190.2 (51 to 454)
Chol Capillary Comparator SST™	192.8 (51 to 457)
Creatinine (Creat) Test Device SST™	2.418 (0.23 to 19.93)
Creat Capillary Comparator SST™	2.432 (0.22 to 20.03)

Population analysed: This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 262 (0%)	0 of 262 (0%)	0 of 262
Comparator Product	0 of 262 (0%)	0 of 262 (0%)	0 of 262

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Capillary Blood Collection System in people with Healthy and Disease, Chronic, run by Becton, Dickinson and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples (time frame: within 4 hours of sample collection). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.