Autonomous Blood Drawing Optimization and Performance Testing (ADOPT)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luuk Giesen, MD
- Phone Number: +31 30 200 45 51
- Email: luuk.giesen@vitestro.com
Study Contact Backup
- Name: Jeroen Roest, MSc
- Phone Number: +31 30 200 45 51
- Email: jeroen.roest@vitestro.com
Study Locations
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-
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Copenhagen, Denmark, 2400
- Recruiting
- Bispebjerg and Frederiksberg Hospital
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Contact:
- Nicolai W Albrechtsen, PhD
- Phone Number: +45 38 63 50 00
- Email: nicolai.albrechtsen@regionh.dk
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Principal Investigator:
- Nicolai W Albrechtsen, PhD
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Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
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Contact:
- Mads Nybo, PhD
- Phone Number: +45 20 55 39 52
- Email: mads.nybo@rsyd.dk
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Principal Investigator:
- Mads Nybo, PhD
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-
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North Holland
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Amsterdam, North Holland, Netherlands, 1105 AZ
- Recruiting
- Amsterdam UMC
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Contact:
- Robert de Jonge, prof. dr.
- Phone Number: +31 20 566 4851
- Email: r.dejonge1@amsterdamumc.nl
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Principal Investigator:
- Robert de Jonge, prof. PhD
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Amsterdam, North Holland, Netherlands, 1091 AC
- Recruiting
- OLVG Lab
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Contact:
- Martine Deckers, PhD
- Phone Number: +31 20 510 89 51
- Email: m.deckers@olvg.nl
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Principal Investigator:
- Martine Deckers, PhD
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South Holland
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Dordrecht, South Holland, Netherlands, 3318 AT
- Recruiting
- Result Laboratorium, location Albert Schweitzer Hospital
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Contact:
- Michael Fouraux, PhD
- Phone Number: +31 78 654 1810
- Email: m.fouraux@resultlaboratorium.nl
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Principal Investigator:
- Michael Fouraux, PhD
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Utrecht
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Nieuwegein, Utrecht, Netherlands, 3435CM
- Recruiting
- St. Antonius Hospital
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Contact:
- Thijs van Holten, PhD
- Phone Number: +31 88 320 7190
- Email: t.van.holten@antoniusziekenhuis.nl
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Principal Investigator:
- Thijs van Holten, PhD
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Utrecht, Utrecht, Netherlands, 3526KS
- Not yet recruiting
- Vitestro
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Contact:
- Luuk Giesen, MD
- Phone Number: +31 30 200 4551
- Email: luuk.giesen@vitestro.com
-
Principal Investigator:
- Luuk Giesen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autonomous blood drawing
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 days
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luuk Giesen, MD, Vitestro B.V.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL80965.000.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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