Autonomous Blood Drawing Optimization and Performance Testing
Recruiting
N/A
Interventional Study
Venipuncture
Phlebotomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 44,658 (estimated)
- Sponsor
- Vitestro B.V. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).
The study consists of several phases (A, B1, B2, B3, C1, C2, C3, 0).
Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawi…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
• Age ≥16 years.
Exclusion Criteria:
* Unable to follow instructions, due to mental disability and/or incapacity
* Unable to use device correctly due to physical impairment or disability (for example a patient with severe contractures or deformities)
* No venipuncture possible…
Contacts