BD MiniDraw™ Capillary System Clinical Equivalence Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186311
• Other study ID #: PAS-21YODA005
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: October 24, 2022

Study information

• Verified date: October 2023
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. 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.

2. 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.

Related Conditions & MeSH terms

• Acute Disease
• Disease, Chronic
• Healthy
• Sample Collection

Intervention

Device:
• Capillary Blood Collection System
Test Blood Sample Collection

Locations

Country	Name	City	State
United States	Babson Diagnostics	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Becton, Dickinson and Company	Babson Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples	To evaluate sample hemolysis as measured by Plasma Free Hemoglobin (PFH) for BD Microtainer® Easy Collect Capillary Tube SST™ and all comparator tube types: capillary and venous	within 4 hours of sample collection
Other	Serum Collection Volume of the Test Device SST Tube	To evaluate serum collection volume of the Test Device SST tube	within 4 hours of sample collection
Other	Duration of Sample Collection for Test Device SST Tube and Comparator Tube	To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator.	within 4 hours of sample collection
Other	Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types	Evaluation of the frequency of occurrence of all instrument flags (both asterisks and IP messages) in the Test Device EDTA and all comparator tube types: venous and capillary tubes	within 4 hours of sample collection
Other	Whole Blood Collection Volume for the Test Device EDTA	To evaluate whole blood collection volume for the Test Device EDTA	within 4 hours of sample collection
Other	Duration of Sample Collection for the Test Device EDTA and Capillary Comparator	To evaluate duration of sample collection for the Test Device EDTA and capillary comparator	within 4 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 2 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 4 hours of sample collection
Primary	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	within 2 hours of sample collection
Primary	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	within 2 hours of sample collection
Primary	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	within 2 hours of sample collection
Primary	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	within 2 hours of sample collection
Primary	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	within 2 hours of sample collection