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

NCT05931926 | Unknown

• 1 other identifier: FLUISPOTTER
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Feasibility - subjects

  Subjects' acceptance of device - Assessed by a questionnaire consisting of 11 questions designed for this study

  Day 2-7

Secondary Outcomes (2)

• Number of succesfull samples by the Fluispotter

  Day 2

• Feasibility - operator

  Day 1

Other Outcomes (1)

• Increase of cortisol due to sampling stress

  through study completion, an average of 1 year

Study Arms (2)

Patients with adrenal insufficiency

10 patients with adrenal insufficiency due to pituitary desease will be recruited for this arm.

Device: Fluispotter®

Healthy controls

10 healthy controls will be recruited for this arm.

Device: Fluispotter®

Interventions

Fluispotter® DEVICE

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.

Healthy controls; Patients with adrenal insufficiency

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with secondary pituitary insufficiency

You may qualify if:

• Not receiving regular medication
• Not receiving oral contraceptives or other oestrogens
• No known endocrine or major medical diseases
• No previous surgery of endocrine glands
• No regular smoking
• Not working nightshifts within the last 14 days before assessment
• Able to understand verbal and written instructions in Danish
• Able and willing to sign informed consent
• A negative pregnancy test one-week prior to admission
• Normal infection-, electrolyte- and coagulation-status assessed by standard blood samples
• Adrenal insufficiency due to pituitary disease
• No previous hormone producing pituitary adenomas
• Not receiving oral contraception or other oestrogens
• Stabil pituitary hormone replacement therapy, including hydrocortisone, for the previous three months
• No cardiac, respiratory or lung disease.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (2)

• Ollerenshaw JD, Schroder M, Velschow S. A novel device for serial venous blood sampling in a canine model. J Pharmacol Toxicol Methods. 2022 Mar-Apr;114:107155. doi: 10.1016/j.vascn.2022.107155. Epub 2022 Jan 14.

  PMID: 35038558 BACKGROUND

• Adhikari KB, Rohde M, Velschow S, Feldt-Rasmussen U, Johannesen J, Johnsen AH. Fluispotter, a novel automated and wearable device for accurate volume serial dried blood spot sampling. Bioanalysis. 2020 May;12(10):665-681. doi: 10.4155/bio-2020-0048. Epub 2020 Jun 3.

  PMID: 32489105 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

hormone measurements

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Ulla Feldt-Rasmussen, Prof

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulla Feldt-Rasmussen, Professor

CONTACT

+45 35 45 10 23; ufeldt@rh.dk

Jesper Krogh, Ass. Prof

CONTACT

+45 25 53 54 85; jesper.krogh.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant Ulla Feldt-Rasmussen

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: July 6, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share