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Autonomous Blood Drawing Optimization and Performance Testing — ADOPT  

Venipuncture Clinical Trial

Official title:
Autonomous Blood Drawing Optimization and Performance Testing

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

Clinical Trial Details
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
View Details
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
Recruiting NCT05831605 - Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light N/A
Completed NCT03004456 - Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population N/A
Completed NCT05727631 - The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture N/A
Completed NCT04027218 - Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. N/A
Recruiting NCT05404594 - Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants N/A
Completed NCT05441241 - Leap Motion Controller for Pain During Venipuncture in Pediatrics N/A
Completed NCT05077345 - The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit
Completed NCT04690257 - Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture N/A
Completed NCT05680649 - Effect of Breathing Exercise During Peripheral Intravenous Catheter N/A
Completed NCT00233844 - Studying the Analgesic Mechanism of the "Cough-Trick" Phase 2
Completed NCT06077409 - ''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters'' N/A
Completed NCT03899766 - Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
Not yet recruiting NCT04983303 - Comparison of the Effectiveness of Distraction N/A
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