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

Sponsors

Lead Sponsor: Fluisense ApS

Collaborator: Dantrials Aps

Source 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.

Overall Status Completed
Start Date 2021-01-27
Completion Date 2021-03-22
Primary Completion Date 2021-03-22
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of samplings 20 hours
Secondary Outcome
Measure Time Frame
Clinical safety, safety reporting 8 ± 2 days
Clinical safety, systemic effects 24 hours
Technical performance 20 hours
Procedure Approximately 60 minutes and 24 hours
Usability: User experience based on questionnaire 24 hours
Usability: Subject experience based on questionnaire 24 hours and 8 ± 2 days
Enrollment 22
Condition
Intervention

Intervention Type: Device

Intervention Name: Fluispotter

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

Arm Group Label: Fluispotter

Other Name: Fluispotter Control System, Fluispotter Cartridge, Fluispotter Catheter 45

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jesper Sonne, MD, DMSc Principal Investigator Dantrials Aps
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: DanTrials ApS
Location Countries

Denmark

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Fluispotter

Type: Experimental

Description: Fluispotter automated blood sampling system

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

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