PocDoc Lipids Usability Study for Self-test Use

Hyperlipidemias Clinical Trial

Official title:

PocDoc Lipids Usability Study for Self-test Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053788
• Other study ID #: 322100
• Status: Completed
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Vital Signs Solutions Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Diagnostic Test:
• PocDoc
Point of care digital lipid test

Locations

Country	Name	City	State
United Kingdom	Vital Signs Solutions Ltd	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Vital Signs Solutions Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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