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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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05878483
Study type Interventional
Source Vitestro B.V.
Contact Luuk Giesen, MD
Phone +31 30 200 45 51
Email luuk.giesen@vitestro.com
Status Recruiting
Phase N/A
Start date July 21, 2023
Completion date July 2025

See also
  Status Clinical Trial Phase
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Completed NCT05374902 - Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children N/A
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Completed NCT03122574 - The Effects of Aromatherapy on the Incidence and Severity of Acute Pain N/A
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Completed NCT03004456 - Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population N/A
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Completed NCT04027218 - Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. N/A
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Completed NCT03899766 - Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
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Completed NCT01115062 - Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children Phase 2
Completed NCT04346732 - Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors N/A