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Completed

NCT Number: NCT04594577

Clinical Validation of the Fluispotter 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.

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Key information

Conditions

Blood Sampling Procedure Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DanTrials ApS

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluispotter

Device

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

Primary outcomes

  1. Number of samplings

    Time frame: 20 hours

    Number of successful samplings over a 20-hour period

Secondary outcomes

  1. Clinical safety, safety reporting

    Time frame: 8 ± 2 days

    Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies

  2. Clinical safety, systemic effects

    Time frame: 24 hours

    Clinical haematology and biochemistry tests before and after 20-hour sampling session

  3. Technical performance

    Time frame: 20 hours

    Details of technical performance (yes, no)

  4. Procedure

    Time frame: Approximately 60 minutes and 24 hours

    Details of procedure, including duration of procedure steps (minutes)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Fluisense ApS

Industry

Collaborators

  • Dantrials Aps

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2020
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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