A multicenter, first-in-human study to investigate a venipuncture device prototype and assess its safety and feasibility
Withdrawn
- Conditions
- de venapunctieblood drawingvenipuncture
- Registration Number
- NL-OMON47958
- Lead Sponsor
- Vitestro B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
* Age *18 years.
* Written signed informed consent must be obtained.
* Able to participate in this study
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility: Number of successful automated venipunctures<br /><br>Safety: number of adverse events and number of adverse device events</p><br>
- Secondary Outcome Measures
Name Time Method <p>Subject's pain experience<br /><br>Duration of device procedure in seconds<br /><br>Causes of missed venipuncture</p><br>