Autonomous Blood Drawing Optimization and Performance Testing

NCT05878483 | Recruiting

• 1 other identifier: NL80965.000.22
• Study Type: interventional
• Target: 13,618
• Locations: 1 country
• Sites: 5

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).

Conditions

Venipuncture; Phlebotomy

Keywords

Autonomous; Blood Drawing; Phlebotomy; Robotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of punctured participants

  Baseline

• Rate of hemolyzed samples

  Baseline

• Adverse Events

  7 days

Study Arms (1)

Autonomous blood drawing

EXPERIMENTAL

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)

Interventions

Venipuncture Device (VD) DEVICE

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.

Autonomous blood drawing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vitestro B.V.: lead

Study Sites (5)

OLVG Lab

Amsterdam, North Holland, 1091 AC, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Result Laboratorium, location Albert Schweitzer Hospital

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

Vitestro

Utrecht, 3526KS, Netherlands

NOT YET RECRUITING

Study Officials

• Luuk Giesen, MD

  Vitestro B.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luuk Giesen, MD

CONTACT

+31 30 200 45 51; luuk.giesen@vitestro.com

Jeroen Roest, MSc

CONTACT

+31 30 200 45 51; jeroen.roest@vitestro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: July 21, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)