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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
22
Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.
DanTrials ApS
Copenhagen, Denmark
Number of samplings
Number of successful samplings over a 20-hour period
Time frame: 20 hours
Clinical safety, safety reporting
Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies
Time frame: 8 ± 2 days
Clinical safety, systemic effects
Clinical haematology and biochemistry tests before and after 20-hour sampling session
Time frame: 24 hours
Technical performance
Details of technical performance (yes, no)
Time frame: 20 hours
Procedure
Details of procedure, including duration of procedure steps (minutes)
Time frame: 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)
Time frame: 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)
Time frame: 24 hours and 8 ± 2 days
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