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Autonomous Blood Drawing Optimization and Performance Testing (ADOPT)

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ClinicalTrials.gov Identifier: NCT05878483
Recruitment Status : Recruiting
First Posted : May 26, 2023
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Venipuncture Phlebotomy Device: Venipuncture Device (VD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13618 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Anticipated number of participants distribution:

Phase A: 1,500 participants (max) Phase B1: 374 participants Phase B2/C1: 1,500 participants (max) Phase C2: 8,744 participants 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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Autonomous Blood Drawing Optimization and Performance Testing
Actual Study Start Date : July 21, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: Autonomous blood drawing

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.

Device: 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, the device has full functionality and only limited manual steps are required to be performed by a device supervisor.





Primary Outcome Measures :
  1. First-time venipuncture success rate [ Time Frame: 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 :
  1. Rate of punctured participants [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05878483


Contacts
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Contact: Luuk Giesen, MD +31 30 200 45 51 luuk.giesen@vitestro.com
Contact: Jeroen Roest, MSc +31 30 200 45 51 jeroen.roest@vitestro.com

Locations
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Netherlands
OLVG Lab Recruiting
Amsterdam, Noord-Holland, Netherlands, 1091 AC
Contact: Martine Deckers, PhD    +31 20 510 89 51    m.deckers@olvg.nl   
Principal Investigator: Martine Deckers, PhD         
Amsterdam UMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Robert de Jonge, prof. dr.    +31 20 566 4851    r.dejonge1@amsterdamumc.nl   
Principal Investigator: Robert de Jonge, prof. dr.         
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435CM
Contact: Thijs van Holten, PhD    +31 88 320 7190    t.van.holten@antoniusziekenhuis.nl   
Principal Investigator: Thijs van Holten, PhD         
Result Laboratorium, location Albert Schweitzer Hospital Recruiting
Dordrecht, Zuid-Holland, Netherlands, 3318 AT
Contact: Michael Fouraux, PhD    +31 78 654 1810    m.fouraux@resultlaboratorium.nl   
Principal Investigator: Michael Fouraux, PhD         
Vitestro Not yet recruiting
Utrecht, Netherlands, 3526KS
Contact: Luuk Giesen, MD    +31 30 200 4551    luuk.giesen@vitestro.com   
Principal Investigator: Luuk Giesen, MD         
Sponsors and Collaborators
Vitestro B.V.
Investigators
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Principal Investigator: Luuk Giesen, MD Vitestro B.V.
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Responsible Party: Vitestro B.V.
ClinicalTrials.gov Identifier: NCT05878483    
Other Study ID Numbers: NL80965.000.22
First Posted: May 26, 2023    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitestro B.V.:
Autonomous
Blood Drawing
Phlebotomy
Robotics