BD MiniDraw™ Capillary System Clinical Equivalence Study

NCT05186311 | Completed Results

• 1 other identifier: PAS-21YODA005
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Disease, Chronic; Acute Disease; Sample Collection

Keywords

sample collection device

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (6)

• Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples

  within 4 hours of sample collection

• Serum Collection Volume of the Test Device SST Tube

  within 4 hours of sample collection

• Duration of Sample Collection for Test Device SST Tube and Comparator Tube

  within 4 hours of sample collection

Study Arms (1)

Test product

EXPERIMENTAL

BD MiniDraw™ Capillary Blood Collection System

Device: Capillary Blood Collection System

Interventions

Capillary Blood Collection System DEVICE

Test Blood Sample Collection

Also known as: BD MiniDraw™ Capillary System

Test product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead
• Babson Diagnostics: collaborator

Study Sites (1)

Babson Diagnostics

Austin, Texas, 78753, United States

Location

MeSH Terms

Conditions

Chronic Disease; Acute Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Becton, Dickinson and Company

Pierre.Asselin@bd.com

9292850651

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 11, 2022
• Study Start: April 22, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 3, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-10

Locations

US (1)