BD MiniDraw™ Capillary System Clinical Equivalence Study
Completed
Conditions studied: Healthy, Disease, Chronic, Acute Disease, Sample Collection
In brief
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.
Key facts
- Study ID
- NCT05186311
- Run by
- Becton, Dickinson and Company
- People needed
- 262
- Starts
- 2022-04-22
- Expected to finish
- 2022-10-24
- Last updated by the study team
- 2023-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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…
- 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.
Where it is running
- Babson Diagnostics — Austin, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.