Autonomous Blood Drawing Optimization and Performance Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorVitestro B.V.
About this trial
The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).
The study consists of several phases (A, B1, B2, B3, C1, C2, C3, 0).
Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing.
Phases A, B2, B3, C1, C2, C3 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection).
The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers can be included in a non-hospital site (Vitestro Site).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Venipuncture Device (VD)
DeviceThe Venipuncture Device is a pre-market medical device that fully automates the blood drawing procedure (also called phlebotomy or venipuncture). It automatically detects a vein using near-infrared and ultrasound imaging technology, robotically inserts a needle, automatically connects blood tubes and applies pressure to the puncture site. During the ADOPT Study, the technology is further improved over time; for example features are released (such as: automated tourniquet). Initially, several manual steps are required to be performed by a device supervisor and operator. At the final stage of the ADOPT Study, Phase C2 and Phase C3, the device has full functionality and only limited manual steps are required to be performed by a device supervisor.
Treatment groups
44,658 Participants
are divided into 1 treatment groupGroup A: Autonomous blood drawingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
First-time venipuncture success rate
Phase A/B1/C1: Success is defined as blood flowing into blood tubes at first attempt; Failure is defined as no blood flowing in the blood tubes at all at first attempt. Phase C2/C3: All blood tubes are filled sufficiently, no second venipuncture is required to obtain (all) the samples. Phase B2/B3: study phase is focused on analytical validation of samples drawn with the device. First-time venipuncture success rate is not the primary endpoint for these Phases.
Time frame
BaselineSecondary outcomes
1
Rate of punctured participants
Phase A/B1/C1: The total number of participants that are punctured by the device is divided by the total number of included participants.
Time frame
Baseline2
Rate of hemolyzed samples
All samples with an (automated) hemolysis-index of \>0.5 hemoglobin g/L, are classified as hemolyzed. In the laboratories where reporting occurs in umol/L, 0.5 g/L is divided by a factor: 0.5 g/L / 1.6129= 31 umol/L.
Time frame
Baseline3
Adverse Events
Number and type of Adverse Events (AE)s and Device Adverse Effects (ADEs) will be recorded and collected. A passive one week (7 days) follow-up occurs to determine whether any delayed adverse events occur.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov