Clinical trial NCT05878483: Autonomous Blood Drawing Optimization and Performance Testing
Official title: Autonomous Blood Drawing Optimization and Performance Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venipuncture
Phlebotomy
Keywords: Autonomous
Blood Drawing
Phlebotomy
Robotics
Lead sponsor: Vitestro B.V.
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 13618
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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).


Eligibility criteria: 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.

Primary outcomes:
measure: First-time venipuncture success rate
timeFrame: Baseline
Secondary outcomes:
measure: Rate of punctured participants
timeFrame: Baseline
measure: Rate of hemolyzed samples
timeFrame: Baseline
measure: Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG Lab
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Dordrecht
country: Netherlands
facility: Result Laboratorium, location Albert Schweitzer Hospital
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Vitestro
Study officials:
affiliation: Vitestro B.V.
name: Luuk Giesen, MD
role: PRINCIPAL_INVESTIGATOR
References: