Status:
COMPLETED
BD MiniDraw™ Capillary System Clinical Equivalence Study
Lead Sponsor:
Becton, Dickinson and Company
Collaborating Sponsors:
Babson Diagnostics
Conditions:
Healthy
Disease, Chronic
Eligibility:
All Genders
18+ years
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 o...
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 finger...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT05186311
Start Date
April 22 2022
End Date
October 24 2022
Last Update
November 3 2023
Active Locations (1)
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1
Babson Diagnostics
Austin, Texas, United States, 78753