VenipunctureADOPTNCT05878483
Autonomous Blood Drawing Optimization and Performance Testing
A study testing Venipuncture Device (VD) in people with Venipuncture and Phlebotomy, run by Vitestro B.V. at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venipuncture, Phlebotomy
- What is being tested?
- Venipuncture Device (VD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44,658 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 21 Jul 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥16 years.
Who cannot join
- 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
Show all 17Show fewer
- 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 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Netherlands5 sites, 5 recruiting
- Recruiting
OLVG Lab
Amsterdam, North Holland, 1091 AC
Martine Deckers, PhD, +31 20 510 89 51, m.deckers@olvg.nl
Martine Deckers, PhD
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Robert de Jonge, prof. dr., +31 20 566 4851, r.dejonge1@amsterdamumc.nl
Robert de Jonge, prof. PhD
- Recruiting
Result Laboratorium, location Albert Schweitzer Hospital
Dordrecht, South Holland, 3318 AT
Michael Fouraux, PhD, +31 78 654 1810, m.fouraux@resultlaboratorium.nl
Michael Fouraux, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Thijs van Holten, PhD, +31 88 320 7190, t.van.holten@antoniusziekenhuis.nl
Thijs van Holten, PhD
- Not yet recruiting
Vitestro
Utrecht, Utrecht, 3526KS
Luuk Giesen, MD, +31 30 200 4551, luuk.giesen@vitestro.com
Luuk Giesen, MD
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg and Frederiksberg Hospital
Copenhagen, 2400
Nicolai W Albrechtsen, PhD, +45 38 63 50 00, nicolai.albrechtsen@regionh.dk
Nicolai W Albrechtsen, PhD
- Recruiting
Odense University Hospital
Odense, 5000
Mads Nybo, PhD, +45 20 55 39 52, mads.nybo@rsyd.dk
Mads Nybo, PhD
About this study
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).
Read more
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).
- Conditions
- Venipuncture, Phlebotomy
- Being tested
- Venipuncture Device (VD)
- Keywords
- Autonomous, Blood Drawing, Phlebotomy, Robotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Autonomous blood drawing | Experimental | Hospital Sites (outpatients visiting blood drawing department):
In study Phase A, 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. Receives: Device: Venipuncture Device (VD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start21 Jul 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 44,658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitestro B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luuk Giesen, MD, Principal investigator, Vitestro B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878483
- Sponsor's protocol ID
- NL80965.000.22
- Acronym
- ADOPT
- Status last verified
- Aug 2026
- First submitted
- 17 May 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Aug 3;72(8):845-856. doi: 10.1093/clinchem/hvag029.
PubMed 41967464
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomous Blood Drawing Optimization and Performance Testing
- ClinicalTrials.gov ID
- NCT05878483
- Acronym / sponsor ID
- ADOPT / NL80965.000.22
- Conditions
- Venipuncture, Phlebotomy
- Keywords
- Autonomous, Blood Drawing, Phlebotomy, Robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44,658 participants (estimated)
- Lead sponsor
- Vitestro B.V.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Autonomous blood drawing | Experimental | Device: Venipuncture Device (VD)Hospital Sites (outpatients visiting blood drawing department): In study Phase A, 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥16 years.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venipuncture 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. | Device | Autonomous blood drawing |
Primary outcome
First-time venipuncture success rate
Time frame: 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.
3 secondary outcomes
Rate of punctured participants
Time frame: Baseline
Rate of hemolyzed samples
Time frame: Baseline
Adverse Events
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Results publication: PubMed 41967464Giesen 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 Aug 3;72(8):845-856. doi: 10.1093/clinchem/hvag029.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luuk Giesen, MD principal investigator
Vitestro B.V.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture Device (VD) in people with Venipuncture and Phlebotomy, run by Vitestro B.V. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luuk Giesen, MD (+31 30 200 45 51, luuk.giesen@vitestro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-time venipuncture success rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.