Autonomous Blood Drawing Optimization and Performance Testing
NCT ID: NCT05878483
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13618 participants
INTERVENTIONAL
2023-07-21
2025-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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.
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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.
16 Years
ALL
Yes
Sponsors
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Vitestro B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Luuk Giesen, MD
Role: PRINCIPAL_INVESTIGATOR
Vitestro B.V.
Locations
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OLVG Lab
Amsterdam, North Holland, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Result Laboratorium, location Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Vitestro
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL80965.000.22
Identifier Type: -
Identifier Source: org_study_id
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