Venous blood drawing blood draw
Conditions
Interventions
One or two automated venipunctures with the VD-1
Sponsors
Vitestro
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=16 years.
Exclusion criteria
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 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) • Incapacitated persons • Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint: - First-time venipuncture success rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Rate of punctured participants - Rate of hemolyzed samples (>0.5 g/l) - Adverse events. | — |
Countries
Denmark, Netherlands
Contacts
Public ContactLFP Giesen
Vitestro
Outcome results
None listed