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CompletedNCT06053788Updated Sep 26, 2023

PocDoc Lipids Usability Study for Self-test Use

An interventional study of PocDoc in Hyperlipidemias, sponsored by Vital Signs Solutions Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Vital Signs Solutions Ltd · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.

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Conditions studied

  • Hyperlipidemias

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 50 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

This is the only study on the registry with Vital Signs Solutions Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Signed informed consent form
  • Subjects are legally competent and capable to understand character, meaning and consequences of the study
  • Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and a link will be contained in the PIS)

Exclusion criteria

Exclusion Criteria:

  • Being unable to give informed consent
  • \< 18 years or > 85 years
  • Legally incompetent
  • Language barriers potentially compromising an adequate compliance with study procedures
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    PocDoc

    All participants given PocDoc device

    Diagnostic Test: PocDoc

Interventions

  • Diagnostic testPocDoc

    Point of care digital lipid test

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What researchers measure

Primary outcomes

  1. Usability

    The usability study will pass our acceptance criteria if 95% of the users are able to successfully conduct a PocDoc lipid test, obtaining a result. The PocDoc lipid test is a rapid 5-marker lipid test in lateral flow format that uses a smartphone application to analyse and display the result. Usability is defined as the ability of an individual to navigate the mobile application steps to conduct the rapid lateral flow test, to take a picture of the image and to navigate to the results page of the application to see their results. A successful test is one where the individual successfully completes all steps and gets their result.

    Time frame: Day 1 - one single test done at one timepoint

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Study locations

1 site
  • Vital Signs Solutions Ltd
    Cambridge, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06053788
Lead sponsor
Vital Signs Solutions Ltd
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Apr 26, 2023
Primary completion
Aug 1, 2023
Completion
Sep 1, 2023
Last update
Sep 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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