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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594577
• Other study ID #: Fluispotter-01
• Secondary ID: EUDAMED CIV-20-1
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: March 22, 2021

Study information

• Verified date: May 2021
• Source: Fluisense ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Sampling Procedure
• Healthy

Intervention

Device:
• Fluispotter
Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 µL samples in a 20 hours sampling session.

Locations

Country	Name	City	State
Denmark	DanTrials ApS	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Fluisense ApS	Dantrials Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of samplings	Number of successful samplings over a 20-hour period	20 hours
Secondary	Clinical safety, safety reporting	Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies	8 ± 2 days
Secondary	Clinical safety, systemic effects	Clinical haematology and biochemistry tests before and after 20-hour sampling session	24 hours
Secondary	Technical performance	Details of technical performance (yes, no)	20 hours
Secondary	Procedure	Details of procedure, including duration of procedure steps (minutes)	Approximately 60 minutes and 24 hours
Secondary	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
Secondary	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