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 : November 1, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | May 17, 2023 | ||||||||
First Posted Date ICMJE | May 26, 2023 | ||||||||
Last Update Posted Date | November 1, 2023 | ||||||||
Actual Study Start Date ICMJE | July 21, 2023 | ||||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Autonomous Blood Drawing Optimization and Performance Testing | ||||||||
Official Title ICMJE | Autonomous Blood Drawing Optimization and Performance Testing | ||||||||
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). |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | 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. Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | 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. |
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Study Arms ICMJE | 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. Intervention: Device: Venipuncture Device (VD)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
13618 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2025 | ||||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: • Age ≥16 years. Exclusion Criteria:
The following contra-indications / exclusion criteria are respected per arm:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Netherlands | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05878483 | ||||||||
Other Study ID Numbers ICMJE | NL80965.000.22 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Vitestro B.V. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Vitestro B.V. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Vitestro B.V. | ||||||||
Verification Date | October 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |