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Robot arm replaces needle? new study puts Auto-Blood draw to the test

NCT ID NCT05878483

Knowledge-focused Sponsor: Vitestro B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study is testing a new robotic device that draws blood automatically. Researchers want to see if it works as well as a human doing it and if it's safe. About 45,000 people aged 16 and older will take part at outpatient blood drawing clinics. The goal is to improve the blood-drawing experience and possibly get regulatory approval for the device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 44,658 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 / 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Phlebotomy Venipuncture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Bispebjerg and Frederiksberg Hospital

    RECRUITING

    Copenhagen, 2400, Denmark

  • OLVG Lab

    RECRUITING

    Amsterdam, North Holland, 1091 AC, Netherlands

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • 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

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