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

May 26, 2021 updated by: Fluisense ApS

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



Intervention / Treatment

Study Type


Enrollment (Actual)



  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2400
        • DanTrials ApS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers


Genders Eligible for Study



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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluispotter
Fluispotter automated blood sampling system
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
Time Frame: 20 hours
Number of successful samplings over a 20-hour period
20 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical safety, safety reporting
Time Frame: 8 ± 2 days
Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies
8 ± 2 days
Clinical safety, systemic effects
Time Frame: 24 hours
Clinical haematology and biochemistry tests before and after 20-hour sampling session
24 hours
Technical performance
Time Frame: 20 hours
Details of technical performance (yes, no)
20 hours
Time Frame: Approximately 60 minutes and 24 hours
Details of procedure, including duration of procedure steps (minutes)
Approximately 60 minutes and 24 hours
Usability: User experience based on questionnaire
Time Frame: 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)
24 hours
Usability: Subject experience based on questionnaire
Time Frame: 24 hours and 8 ± 2 days
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

This is where you will find people and organizations involved with this study.




  • Principal Investigator: Jesper Sonne, MD, DMSc, DanTrials ApS

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


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