PocDoc Lipids Out-of-Surgery Study

Status Recruiting

Clinical Trial Summary

This study seeks to improve access to lipid testing in out-of-surgery locations using PocDoc, a UKCA approved IVD device that measures a full 5 marker lipid panel using a smartphone or tablet. The study will investigate whether PocDoc can close the gap in people not tested by exploring 3 new out-of-surgery methods: 1. Lipid testing conducted in pharmacy or at-home for high-risk individuals on existing CVD register who have not attended in-surgery appointments 2. Footfall lipid testing conducted in pharmacy for individuals visiting or passing by pharmacies 3. Corporate wellness lipid testing performed by employers for employees as part of an organised corporate wellness check

Clinical Trial Description

Lipid testing in out-of-surgery (OOS) locations using a digital lipid measuring device called PocDoc promises to increase access to lipid testing and cardiovascular disease health assessment. PocDoc lipids comprises a smartphone-compatible disposable microchip test strip which uses proprietary colorimetric microfluidic technology to accurately detect lipid biomarkers from a droplet of blood. PocDoc Lipids Professional was launched in 2022 to enable professional users to perform lipid screens as part of lifestyle or preventative healthcare screens. The investigator's hypothesise that providing easier, more cost-effective access to lipid testing at scale, without patients having to attend the GP surgery could: 1. Identify previously unidentified patients (including key "hard to reach" cohorts) who have elevated lipid levels and get them into a lipid lowering clinical pathway which reduces risk of CVD event 2. Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events 3. Identify more cases of undiagnosed FH and getting those patients into a lipid lowering pathway The SBRI 21 Phase 3 program is funding this collaborative project in partnership with SMASH PCN and AHSN NENC with the objective of increasing access to lipid testing in those geographies. ;

Study Design

Related Conditions & MeSH terms

Dyslipidemias

Clinical Trial Details

NCT number	NCT06258005
Study type	Observational
Source	Vital Signs Solutions Ltd
Contact	Kiran Roest, PhD
Phone	+41799167073
Email	kiran@mypocdoc.com
Status	Recruiting
Phase
Start date	June 23, 2023
Completion date	December 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.