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

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

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 Overview

• Status: Completed
• Conditions: Healthy; Blood Sampling Procedure
• Intervention / Treatment: Device: Fluispotter

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • DanTrials ApS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fluisense ApS
• Collaborators: Dantrials Aps
• Investigators: Principal Investigator: Jesper Sonne, MD, DMSc, DanTrials ApS

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Fluispotter-01; EUDAMED CIV-20-10-038466 (Other Identifier: Danish Medicines Agency); Journal no. 2020100544 (Other Identifier: Danish Medicines Agency); Journal no. H-20068538 (Other Identifier: Scientific Ethics Committee for the Capital Region, Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No