The primary objective is to investigate feasibility (number of successful automated venipunctures) and safety (number of adverse events and adverse device events). Secondary objectives are to determine subject's pain experience, duration of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
de venapunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility: Number of successful automated venipunctures
Safety: number of adverse events and number of adverse device events
Secondary outcome
Subject's pain experience
Duration of device procedure in seconds
Causes of missed venipuncture
Background summary
Venipuncture is one of the most common invasive medical procedures in the
world. Although the analysis of blood samples and post-analytical validation
has been fully automated, the actual collection of blood remains a manual
process. Missed punctures is a potential cause of complications. Furthermore,
manual venipuncture is an important cause of laboratory errors and incurs high
costs. Automation of venipuncture offers an intriguing opportunity for
improving patient outcome while reducing operational costs. Vitestro has
developed a prototype of a venipuncture device (VDPA) that will be tested in
this feasibility study. This clinical investigation presents the first step
towards a fully autonomous venipuncture device.
Study objective
The primary objective is to investigate feasibility (number of successful
automated venipunctures) and safety (number of adverse events and adverse
device events). Secondary objectives are to determine subject's pain
experience, duration of device procedureand causes of missed venipuncture.
Study design
A feasibility study, non-randomised. Subjects will have one venipuncture with
the venipuncture device prototype A (VDPA)
Intervention
Automated venipuncture by the VDPA in one arm
Study burden and risks
The burden for subjects consist of a one-time visit to the hospital blood
drawing department, during which subjects undergo an automated venipuncture in
1 arm. Afterwards, subjects will answer questions. Risks of the device are
those associated with manual venipuncture, most important complications are
hematoma and vasovagal syncope. Several control measures were taken to prevent
risks: de depth of needle insertion is limited, the prototype will only insert
a needle in case of adequate 3D reconstruction of ultrasound images, the
identified puncture location is verified by research phlebotomist.
Europalaan 500 1.N.2
Utrecht 3526KS
NL
Europalaan 500 1.N.2
Utrecht 3526KS
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL69427.015.19 |