Autonomous Blood Drawing Optimization and Performance Testing
- Conditions
- VenipuncturePhlebotomy
- Interventions
- Device: Venipuncture Device (VD)
- Registration Number
- NCT05878483
- Lead Sponsor
- Vitestro B.V.
- 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, C1, C2, 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, C1, C2 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 is included in a non-hospital site (Vitestro Site).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 13618
• Age ≥16 years.
- 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 / exclusion criteria are respected per arm:
- Arteriovenous fistula or vascular graft
- Paretic or paralyzed arm (e.g. after stroke or trauma)
- Infected skin in cubital fossa (for example: erysipelas or cellulitis)
- Mastectomy side, axillary lymph node excised
- Healed skin burns in cubital fossa
- Edema in cubital fossa
- Extensive scarring in cubital fossa
- Hematoma in cubital fossa
- Tattoos in cubital fossa
In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2, a manual venipuncture and automated venipuncture are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autonomous blood drawing Venipuncture Device (VD) Hospital Sites (outpatients visiting blood drawing department): In study Phase A1, B1, B2, C1, a subject visiting the outpatient blood drawing department will receive one automated blood draw with the Venipuncture Device. This blood draw is additional to the manual blood draw. In study Phase C2 the automated blood draw replaces the manual blood draw. In Phase C2, the subject might therefore receive two automated blood draws, in case a redraw is required. Vitestro Site (volunteers): In study Phase A, C1 volunteers visit Vitestro Site. Participants receive one to two automated blood draws.
- Primary Outcome Measures
Name Time Method First-time venipuncture success rate Baseline Phase A/B1/B2/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: All blood tubes are filled sufficiently, no second venipuncture is required to obtain (all) the samples.
- Secondary Outcome Measures
Name Time Method Rate of punctured participants Baseline The total number of participants that are punctured by the device is divided by the total number of included participants.
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.
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.
Trial Locations
- Locations (5)
St. Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
OLVG Lab
🇳🇱Amsterdam, Noord-Holland, Netherlands
Amsterdam UMC
🇳🇱Amsterdam, Noord-Holland, Netherlands
Vitestro
🇳🇱Utrecht, Netherlands
Result Laboratorium, location Albert Schweitzer Hospital
🇳🇱Dordrecht, Zuid-Holland, Netherlands