NCT06053788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 6, 2023

Last Update Submit

September 18, 2023

Conditions

Hyperlipidemias

Outcome Measures

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.

    Day 1 - one single test done at one timepoint

Study Arms (1)

PocDoc

EXPERIMENTAL

All participants given PocDoc device

Diagnostic Test: PocDoc

Interventions

PocDocDIAGNOSTIC_TEST

Point of care digital lipid test

PocDoc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vital Signs Solutions Ltd

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 26, 2023

Study Start

April 26, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)