PocDoc Lipids Usability Study for Self-test Use

Vital Signs Solutions

Status: Completed

Conditions: Hyperlipidemias

Treatments: Diagnostic Test: PocDoc

Study type: Interventional

Funder types: Industry

Identifiers

NCT06053788

322100

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

PocDoc

Experimental group

Description:

All participants given PocDoc device

Treatment:

Diagnostic Test: PocDoc