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

NCT04594577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-05-27

No results posted yet for this study

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

Interventions

DEVICE

Fluispotter

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

Sponsors & Collaborators

  • Dantrials Aps

    collaborator INDUSTRY

  • Fluisense ApS

    lead INDUSTRY

Principal Investigators

  • Jesper Sonne, MD, DMSc · Dantrials Aps

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2021-03-22
Completion
2021-03-22

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594577 on ClinicalTrials.gov