Autonomous Blood Drawing Optimization and Performance Testing

Recruiting

• Conditions: veneuze bloedafname; Venous blood drawing

• Registration Number: NL-OMON53917
• Lead Sponsor: Vitestro B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 13618

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint:<br /><br>- First-time venipuncture success rate. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Rate of punctured participants<br /><br>- Rate of hemolyzed samples (>0.5 g/l)<br /><br>- Adverse events. </p><br>