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

Fluisense

Status

Completed

Conditions

Blood Sampling Procedure

Healthy

Treatments

Device: Fluispotter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04594577

Journal no. H-20068538 (Other Identifier)

EUDAMED CIV-20-10-038466 (Other Identifier)

Journal no. 2020100544 (Other Identifier)

Fluispotter-01

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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