Blood Sampling Procedure, Healthy
Conditions
Brief summary
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.
Interventions
DEVICEFluispotter
Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.
Sponsors
Dantrials Aps
Fluisense ApS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of samplings | 20 hours | Number of successful samplings over a 20-hour period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical safety, systemic effects | 24 hours | Clinical haematology and biochemistry tests before and after 20-hour sampling session |
| Technical performance | 20 hours | Details of technical performance (yes, no) |
| Clinical safety, safety reporting | 8 ± 2 days | Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies |
| Usability: User experience based on questionnaire | 24 hours | Usability questions related to use and disposal of system (1= Strongly disagree, 2 = Mildly disagree, 3 = Indifferent, 4 = Mildly agree, 5 = Mildly agree) |
| Usability: Subject experience based on questionnaire | 24 hours and 8 ± 2 days | Usability questions related to pain and disturbance ((VAS) scale straight horizontal line of fixed length 10 cm) |
| Procedure | Approximately 60 minutes and 24 hours | Details of procedure, including duration of procedure steps (minutes) |
Countries
Denmark
Outcome results
None listed