Dip Home-Based Dipstick Analyzer Performance Evaluation

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.

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Key information

Conditions

Urine Detectable Acute and Chronic Diseases Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Center for Medical Research, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women 18-80 years of age
Subjects who are healthy or pregnant; or
Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
Subject is capable and willing to provide informed consent.
Subject has facility with both hands.
Subject is capable and willing to adhere to the study procedures

Treatment and study plan

Experimental: Dip Home-Based Dipstick Analyzer

Device

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 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.

Primary outcomes

Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.

Time frame: 11 months

Secondary outcomes

Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions

Time frame: 11 months

Sponsors and collaborators

Lead sponsor

Healthy.io Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 10, 2020
Registry last updated: Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed