Clinical Validation of the Fluispotter System for Serial... | NCT04594577

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

NCT04594577

Sponsor

Fluisense ApS

Status

Completed

Last Update Posted

May 27, 2021Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Blood Sampling Procedure
Healthy

Interventions

Fluispotter

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
EUDAMED CIV-20-10-038466	Other Identifier	Danish Medicines Agency
Journal no. 2020100544	Other Identifier	Danish Medicines Agency
Journal no. H-20068538	Other Identifier	Scientific Ethics Committee for the Capital Region, Denmark

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2021Actual

Primary Completion Date

Mar 22, 2021Actual

Completion Date

Mar 22, 2021Actual

First Submitted Date

Oct 14, 2020

First Submission Date that Met QC Criteria

Oct 14, 2020

First Posted Date

Oct 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2021

Last Update Posted Date

May 27, 2021Actual

Name	Class
Dantrials Aps	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluispotter	Experimental	Fluispotter automated blood sampling system	Device: Fluispotter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluispotter	Device	Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.	Fluispotter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of samplings	Number of successful samplings over a 20-hour period	20 hours

Secondary Outcomes

Measure	Description	Time Frame
Clinical safety, safety reporting	Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies	8 ± 2 days
Clinical safety, systemic effects	Clinical haematology and biochemistry tests before and after 20-hour sampling session

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jesper Sonne, MD, DMSc	Dantrials Aps	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
DanTrials ApS		Copenhagen		2400	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided