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

NCT04594577 | Completed

• 4 other identifiers: Fluispotter-01EUDAMED CIV-20-10-038466Journal no. 2020100544Journal no. H-20068538
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of samplings

  Number of successful samplings over a 20-hour period

  20 hours

Secondary Outcomes (6)

• 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

Study Arms (1)

Fluispotter

EXPERIMENTAL

Fluispotter automated blood sampling system

Device: Fluispotter

Interventions

Fluispotter DEVICE

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

Also known as: Fluispotter Control System, Fluispotter Cartridge, Fluispotter Catheter 45

Fluispotter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fluisense ApS: lead
• Dantrials Aps: collaborator

Study Sites (1)

DanTrials ApS

Copenhagen, 2400, Denmark

Location

Study Officials

• Jesper Sonne, MD, DMSc

  Dantrials Aps

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: January 27, 2021
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)