Autonomous Blood Drawing Optimization and Performance Testing

Venipuncture Clinical Trial

— ADOPT  

Official title:

Autonomous Blood Drawing Optimization and Performance Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878483
• Other study ID #: NL80965.000.22
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Vitestro B.V.
• Contact: Luuk Giesen, MD
• Phone: +31 30 200 45 51
• Email: luuk.giesen[@]vitestro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13618
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Phlebotomy
• Venipuncture

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	OLVG Lab	Amsterdam	Noord-Holland
Netherlands	Result Laboratorium, location Albert Schweitzer Hospital	Dordrecht	Zuid-Holland
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Vitestro	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Vitestro B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-time venipuncture success rate	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.	Baseline
Secondary	Rate of punctured participants	The total number of participants that are punctured by the device is divided by the total number of included participants.	Baseline
Secondary	Rate of hemolyzed samples	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
Secondary	Adverse Events	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