N/A
N=136
BD MiniDraw™ Capillary System Clinical Equivalence Study
Healthy · Disease, Chronic · Acute Disease · Sample Collection
Bottom Line
View on ClinicalTrials.gov: NCT05186311 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples — 3.746; 3.787; 6.77; 6.83 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capillary Blood Collection System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Becton, Dickinson and Company
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples |
3.746; 3.787; 6.77; 6.83; 3.791; 6.78 | — |
| PRIMARY White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
0.73; 0.71; 0.71; 2.97; 3.16; 2.89 | — |
| PRIMARY Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples |
4.7599; 5.4529; 5.4211 | — |
| PRIMARY Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples |
21.9; 22; 9.43; 9.52; 190.2; 192.8 | — |
| PRIMARY Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples |
107.37; 107.11; 21.72; 24.02; 4.436; 4.506 | — |
| PRIMARY Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples |
41.784; 36.786; 37.603 | — |
| PRIMARY Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples |
98.6; 98.9; 50.2; 51; 47.4; 49.5 | — |
| PRIMARY White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
275.3; 297; 262.1; 12.647; 12.453; 12.746 | — |
| PRIMARY Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
4.43; 4.375; 4.471 | — |
| PRIMARY Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
89.38; 90.16; 89.66; 44.14; 44.97; 44.32 | — |
| PRIMARY Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
13.33; 13.13; 13.45; 33.81; 33.4; 33.69 | — |
| PRIMARY Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) |
30.22; 30.12; 30.21 | — |
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.
Eligibility Criteria
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT05186311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.