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

Not Applicable

Completed

• Conditions: Blood Sampling Procedure; Healthy
• Interventions: Device: Fluispotter

• Registration Number: NCT04594577
• Lead Sponsor: Fluisense ApS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2021-01-27
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluispotter	Fluispotter	Fluispotter automated blood sampling system

Primary Outcome Measures

Name	Time	Method
Number of samplings	20 hours	Number of successful samplings over a 20-hour period

Secondary Outcome Measures

Name	Time	Method
Clinical safety, safety reporting	8 ± 2 days	Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies
Procedure	Approximately 60 minutes and 24 hours	Details of procedure, including duration of procedure steps (minutes)
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)
Technical performance	20 hours	Details of technical performance (yes, no)
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)
Clinical safety, systemic effects	24 hours	Clinical haematology and biochemistry tests before and after 20-hour sampling session

Trial Locations

Locations (1)

DanTrials ApS; 🇩🇰 Copenhagen, Denmark