NCT04466774

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Healthy.io Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urine Detectable Acute and Chronic Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dip Home-Based Dipstick Analyzer	The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
DEVICE	Urine analysis predicate device for professional user	Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.

Timeline

• Start date: 2017-03-05
• Primary completion: 2017-07-30
• Completion: 2017-09-30
• First posted: 2020-07-10
• Last updated: 2020-07-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study