Blood Sampling ProcedureNCT04594577
Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots
A study testing Fluispotter in people with Blood Sampling Procedure and Healthy, run by Fluisense ApS at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Sampling Procedure, Healthy
- What is being tested?
- Fluispotter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jan 2021to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Validation of Fluispotter®, a Novel Automated Body-worn System for Serial Sampling of Venous Dried Blood Spots
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
- Being tested
- Fluispotter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluispotterDevice
Also called Fluispotter Control System, Fluispotter Cartridge, Fluispotter Catheter 45
Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.
| Study group | Role | What they receive |
|---|---|---|
| Fluispotter | Experimental | Fluispotter automated blood sampling system Receives: Device: Fluispotter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of samplings
Number of successful samplings over a 20-hour period
Measured: 20 hours
Secondary outcomes (6)
Clinical safety, safety reporting
Frequency and severity of adverse events (AEs), adverse device effects (ADEs) and device deficiencies
Measured: 8 ± 2 days
Clinical safety, systemic effects
Clinical haematology and biochemistry tests before and after 20-hour sampling session
Measured: 24 hours
Technical performance
Details of technical performance (yes, no)
Measured: 20 hours
Procedure
Details of procedure, including duration of procedure steps (minutes)
Measured: Approximately 60 minutes and 24 hours
Usability: User experience based on questionnaire
Usability questions related to use and disposal of system (1= Strongly disagree, 2 = Mildly disagree, 3 = Indifferent, 4 = Mildly agree, 5 = Mildly agree)
Measured: 24 hours
Usability: Subject experience based on questionnaire
Usability questions related to pain and disturbance ((VAS) scale straight horizontal line of fixed length 10 cm)
Measured: 24 hours and 8 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start27 Jan 2021
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sampling ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluisense ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps
- Responsible party
- Sponsor
- Investigators
- Jesper Sonne, MD, DMSc, Principal investigator, Dantrials Aps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594577
- Sponsor's protocol ID
- Fluispotter-01
- Other IDs
- EUDAMED CIV-20-10-038466, Journal no. 2020100544, Journal no. H-20068538
- Status last verified
- May 2021
- First submitted
- 14 Oct 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Validation of Fluispotter®, a Novel Automated Body-worn System for Serial Sampling of Venous Dried Blood Spots
- ClinicalTrials.gov ID
- NCT04594577
- Acronym / sponsor ID
- Fluispotter-01
- Conditions
- Blood Sampling Procedure, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fluisense ApSIndustry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluispotter | Experimental | Device: FluispotterFluispotter automated blood sampling system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluispotterAlso: Fluispotter Control System, Fluispotter Cartridge, Fluispotter Catheter 45Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session. | Device | Fluispotter |
Primary outcome
Number of samplings
Time frame: 20 hours
Number of successful samplings over a 20-hour period
6 secondary outcomes
Clinical safety, safety reporting
Time frame: 8 ± 2 days
Clinical safety, systemic effects
Time frame: 24 hours
Technical performance
Time frame: 20 hours
Procedure
Time frame: Approximately 60 minutes and 24 hours
Usability: User experience based on questionnaire
Time frame: 24 hours
Usability: Subject experience based on questionnaire
Time frame: 24 hours and 8 ± 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Sonne, MD, DMSc principal investigator
Dantrials Aps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluispotter in people with Blood Sampling Procedure and Healthy, run by Fluisense ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of samplings (time frame: 20 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.