Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots

Study Overview
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Brief Summary
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This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter. The main aim is to validate the clinical performance and safety of the body-worn Fluispotter system used for automated extraction, collection and storage of 20 dried venous dried blood spot samples of 10 µl over the course of 20 hours.

Official Title
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The Clinical Validation of Fluispotter®, a Novel Automated Body-worn System for Serial Sampling of Venous Dried Blood Spots

Conditions
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Blood Sampling Procedure, Healthy

Intervention / Treatment
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* Device: Fluispotter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age ≥ 18 Able to understand verbal and written instructions in Danish Able and willing to sign and date the informed written consent form and letter of authority Exclusion Criteria: Currently participating in a clinical trial evaluating drugs or medical devices Known history of coagulation disorders Currently taking regular medication (contraceptives, hormonal replacement therapy and antihistamines exempted) Regular smoking or use of nicotine products Pregnancy Haematocrit < 38% (male); < 33% (female) Haematocrit > 52% (male); > 48% (female) C-reactive protein (CRP) > 10 mg/dL Body Mass Index (BMI) > 30 Known allergies or hypersensitivity to flushing solution constituents Other factors which in the opinion of the investigator would interfere with the ability to provide informed consent, comply with study procedures/instructions, or possibly confound the interpretation of the study results or put the subject at undue risk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluispotter<br>Fluispotter automated blood sampling system | Device: Fluispotter<br>* Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.<br>* Other names: Fluispotter Control System, Fluispotter Cartridge, Fluispotter Catheter 45;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of samplings | Number of successful samplings over a 20-hour period | 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety, safety reporting | Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies | 8 ± 2 days | 
| Clinical safety, systemic effects | Clinical haematology and biochemistry tests before and after 20-hour sampling session | 24 hours | 
| Technical performance | Details of technical performance (yes, no) | 20 hours | 
| Procedure | Details of procedure, including duration of procedure steps (minutes) | Approximately 60 minutes and 24 hours | 
| Usability: User experience based on questionnaire | Usability questions related to use and disposal of system (1= Strongly disagree, 2 = Mildly disagree, 3 = Indifferent, 4 = Mildly agree, 5 = Mildly agree) | 24 hours | 
| Usability: Subject experience based on questionnaire | Usability questions related to pain and disturbance ((VAS) scale straight horizontal line of fixed length 10 cm) | 24 hours and 8 ± 2 days |