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

NCT ID: NCT04594577

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2021-03-22

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.

Conditions

Blood Sampling Procedure; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fluispotter

Fluispotter automated blood sampling system

Group Type: EXPERIMENTAL

Fluispotter

Intervention Type: DEVICE

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

Interventions

Fluispotter

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

Intervention Type: DEVICE

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dantrials Aps

INDUSTRY

Sponsor Role: collaborator

Fluisense ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesper Sonne, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Dantrials Aps

Locations

DanTrials ApS

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

EUDAMED CIV-20-10-038466

Identifier Type: OTHER

Identifier Source: secondary_id

Journal no. 2020100544

Identifier Type: OTHER

Identifier Source: secondary_id

Journal no. H-20068538

Identifier Type: OTHER

Identifier Source: secondary_id

Fluispotter-01

Identifier Type: -

Identifier Source: org_study_id