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NCT Number: NCT05878483

Autonomous Blood Drawing Optimization and Performance Testing

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).

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Key information

Conditions

Venipuncture Phlebotomy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, North Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of punctured participants

    Time frame: 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.

  2. Rate of hemolyzed samples

    Time frame: 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.

  3. Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Roest, MSc

CONTACT

[email protected]

+31 30 200 45 51

Luuk Giesen, MD

CONTACT

[email protected]

+31 30 200 45 51

Sponsors and collaborators

Lead sponsor

Vitestro B.V.

Industry

Registry information

Acronym: ADOPT

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
May 26, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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