This study has several objectives, in different (subsequent) study phases:• A1. Optimize and validate the technology of the VD to reach non-inferiority• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking• B2. Demonstrate…
ID
Source
Brief title
Autonomous Blood Drawing
Condition
- Other condition
Synonym
Health condition
veneuze bloedafname
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint:
- First-time venipuncture success rate.
Secondary outcome
Secondary endpoints:
- Rate of punctured participants
- Rate of hemolyzed samples (>0.5 g/l)
- Adverse events.
Background summary
The venipuncture procedure is one of the most common invasive medical
procedures in the world. There is a shortage of healthcare personnel, which
limits blood drawing capacity, reducing access and availability of care. This
is of particular importance during pandemics.
Vitestro has spent five years developing an autonomous blood drawing device,
the VD. The VD can draw a blood sample using state of the art intelligent
technology and robotics. With the VD, for the first time, an invasive patient
procedure can be performed autonomously. A prototype has been tested clinically
in the BRAVE Study in >1,000 participants in four different sites. The ADOPT
Study builds on the results and learnings from the BRAVE Study.
Study objective
This study has several objectives, in different (subsequent) study phases:
• A1. Optimize and validate the technology of the VD to reach non-inferiority
• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking
• B2. Demonstrate analytical performance for clinical implementation
• C1. Optimize and further validate the technology of the VD to reach
equivalence
• C2. Implement and optimize the VD in the real-use setting, to reach
equivalence
• 0. Non-invasive VD testing for miscellaneous technology improvement.
Study design
Study design:
Prospective interventional study, open label.
Phase A: exploratory.
Phase B1: confirmatory
Phase B2: exploratory
Phase C1 and Phase C2: exploratory.
Phase 0: exploratory
Design: non-inferiority (only phase B1).
Control group: manual venipuncture (only phase B2).
Intervention
An automated venipuncture with the VD-1
Study burden and risks
The burden for participants consist of one or two venipunctures, 5-20 minutes
in total. The risks are considered comparable to manual venipuncture.
Europalaan 500
Utrecht 3526KS
NL
Europalaan 500
Utrecht 3526KS
NL
Listed location countries
Age
Inclusion criteria
• Age >=16 years.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80965.000.22 |