Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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, 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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autonomous blood drawing | Experimental | 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 and Phase C3 the automated blood draw replaces the manual blood draw. In both Phases, the subject might therefore receive two automated blood draws, in case a redraw is required. In study Phase B3, the automated blood draw also replaces the manual blood draw. The subject will receive two automated blood draws. Vitestro Site (volunteers): In study Phase A, C1 volunteers visit Vitestro Site. Participants receive one to two automated blood draws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venipuncture Device (VD) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Rate of hemolyzed samples |
Not provided
Inclusion Criteria:
• Age ≥16 years.
Exclusion Criteria:
The following contra-indications / exclusion criteria are respected per arm:
In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2 or B3, venipunctures are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 and Phase B3 study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luuk Giesen, MD | Contact | +31 30 200 45 51 | luuk.giesen@vitestro.com | |
| Jeroen Roest, MSc | Contact | +31 30 200 45 51 | jeroen.roest@vitestro.com |
| Name | Affiliation | Role |
|---|---|---|
| Luuk Giesen, MD | Vitestro B.V. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG Lab | Recruiting | Amsterdam | North Holland | 1091 AC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41967464 | Derived | Giesen LFP, Roest JA, Koopman FMA, Deckers MML, Chon H, Hackeng CM, Riedl JA, de Bruin M, Katzman BM, van Gelder W, Cadamuro J, Nybo M, Fouraux MA, van Holten TC, de Jonge R. Performance, Safety, and Patient Experience of an Autonomous Robotic Phlebotomy Device: A Multicenter Trial. Clin Chem. 2026 Apr 10:hvag029. doi: 10.1093/clinchem/hvag029. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Anticipated number of participants distribution:
Phase A: 354 participants Phase B1: 350 participants Phase B2: 420 (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 B1 should be completed before Phase B2/C1 can start. Phase B2 should be completed before Phase C2 can start. Phase C2 should be completed before Phase C3 can start.
Not provided
Not provided
Not provided
Not provided
|
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.
| Baseline |
| 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. | 7 days |
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
|
| Result Laboratorium, location Albert Schweitzer Hospital | Recruiting | Dordrecht | South Holland | 3318 AT | Netherlands |
|
| St. Antonius Hospital | Recruiting | Nieuwegein | Utrecht | 3435CM | Netherlands |
|
| Vitestro | Not yet recruiting | Utrecht | Utrecht | 3526KS | Netherlands |
|