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PocDoc Lipids Usability Study for Self-test Use

Sponsor
Vital Signs Solutions Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT06053788
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
4.2
Actual Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PocDoc
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
PocDoc Lipids Usability Study for Self-test Use
Actual Study Start Date :
Apr 26, 2023
Actual Primary Completion Date :
Aug 1, 2023
Actual Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PocDoc

All participants given PocDoc device

Diagnostic Test: PocDoc
Point of care digital lipid test

Outcome Measures

Primary Outcome Measures

  1. Usability [Day 1 - one single test done at one timepoint]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • Being unable to give informed consent

  • < 18 years or > 85 years

  • Legally incompetent

  • Language barriers potentially compromising an adequate compliance with study procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vital Signs Solutions Ltd Cambridge United Kingdom

Sponsors and Collaborators

  • Vital Signs Solutions Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vital Signs Solutions Ltd
ClinicalTrials.gov Identifier:
NCT06053788
Other Study ID Numbers:
  • 322100
First Posted:
Sep 26, 2023
Last Update Posted:
Sep 26, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperlipidemias

Study Results

No Results Posted as of Sep 26, 2023