Phlebotomy, Venipuncture
Conditions
Keywords
Autonomous, Blood Drawing, Phlebotomy, Robotics
Brief summary
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).
Interventions
DEVICEVenipuncture Device (VD)
The 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.
Sponsors
Vitestro B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Anticipated number of participants distribution: Phase A: 354 participants Phase B1: 350 participants Phase B2: 420 (max) Phase B3: 1050 (max) Phase C1: 2,250 participants (max) Phase C2: 8,744 participants Phase C3: 30,000 participants (max) Phase 0: 1,500 participants (max) The Phases are sequential, reflective of technology development: Phase A should be completed before Phase B1/B2 can start. Phase B1 should be completed before Phase C1 can start. Phase B1/B2 should be completed before Phase C2 can start. Phase C2 should be completed before Phase C3 can start.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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 The following contra-indications /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-time venipuncture success rate | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of punctured participants | Baseline | Phase A/B1/C1: The total number of participants that are punctured by the device is divided by the total number of included participants. |
| Rate of hemolyzed samples | Baseline | 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. |
| Adverse Events | 7 days | 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. |
Countries
Denmark, Netherlands
Contacts
CONTACTLuuk Giesen, MD
CONTACTJeroen Roest, MSc
PRINCIPAL_INVESTIGATORLuuk Giesen, MD
Vitestro B.V.
Outcome results
None listed