de venapunctie blood drawing venipuncture
Conditions
Interventions
Automated venipuncture by the VDPA in one arm
Sponsors
Vitestro B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age *18 years. * Written signed informed consent must be obtained. * Able to participate in this study
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Unable to follow instructions. * Previous chemotherapy or intravenous drug use * Diseases that are associated with poor vein conditions, such as hemophilia * Coagulation disorders or use of anticoagulants * Contra-indications for venipuncture in the cubital fossa (e.g. due to local skin disease, burns, edema, hematoma, previous lymph node extirpation, an arteriovenous fistula, or a paretic/ paralyzed arm) * Recurrent vasovagal reactions during venipuncture * Tattoos in the cubital fossa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Number of successful automated venipunctures Safety: number of adverse events and number of adverse device events | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's pain experience Duration of device procedure in seconds Causes of missed venipuncture | — |
Countries
Netherlands
Outcome results
None listed