A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer

Urine Detectable Acute and Chronic Diseases Clinical Trial

Official title: A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer

Status Completed

Clinical Trial Summary

The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board.

The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Disease
• Urine Detectable Acute and Chronic Diseases

• NCT number: NCT04466774
• Study type: Interventional
• Source: Healthy.io Ltd.
• Status: Completed
• Phase: N/A
• Start date: March 5, 2017
• Completion date: September 30, 2017