Autonomous Blood Drawing Optimization and Performance Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorVitestro B.V.
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, 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 drawing.
Phases A, B2, B3, C1, C2, C3 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection).
The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers can be included in a non-hospital site (Vitestro Site).
Eligibility criteria
Qualifiers
None
Disqualifiers
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 in cubital fossa of both arms (for example: after amputation of both arms)
No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms)
Trial design
Treatments tested in this trial
- Venipuncture Device (VD)
Treatment groups
44,658 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov