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Feasibility and Validation of the Fluispotter®, a Novel Intravenous System for Serial Blood Sampling

NCT05931926 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-07-06

No results posted yet for this study

Summary

The purpose of this study is to test the Fluispotter® technology: A novel system for collection of serial venous samples, which may overcome some of the problems associated with repeated sampling or 20-hour collection of blood samples using standard procedures. The Fluispotter® is the first fully automated, wearable device for obtaining serial blood samples from humans. It is designed to function without operator intervention. The wearable device and - when in place - painless sampling allow sampling during different situations e.g., during sleep, work, play or exercise - whatever the sampling situation requires, including sampling not possible today using wet samples e.g. during everyday activities. Further, it reduces the number of man-hours needed for serial sampling, and minimizes the risks of sample loss, wrong timing, misidentification and contamination.

The primary purpose of this investigator-initiated study is to assess the feasibility, including benefits and harms, of the Fluispotter®, a novel method for serial blood sampling, versus standard blood sampling. The planned setting is a test of the Fluispotter® is a 20-hour period in healthy adults and in adults with secondary adrenal insufficiency due to pituitary disease.

Conditions

Interventions

DEVICE

Fluispotter®

The Fluispotter® has been developed for automated extraction, collection and storage of up to 20 dried venous dried blood spot samples of 3-10 μl over the course of up to 20 hours. The system is attached to the patient through a multilumen microcatheter inserted into a peripheral vein in the arm. The Fluispotter will be inserted in both healthy subjects and patients with adrenal insufficiency.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ulla Feldt-Rasmussen, Prof · Rigshospitalet, Denmark

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-01
Completion
2025-11-01

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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 NCT05931926 on ClinicalTrials.gov