Dip Home-Based Dipstick Analyzer Performance Evaluation
Completed · Not applicable
Conditions studied: Urine Detectable Acute and Chronic Diseases
In brief
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.
Key facts
- Study ID
- NCT04465682
- Run by
- Healthy.io Ltd.
- People needed
- 250
- Starts
- 2018-04-05
- Expected to finish
- 2018-06-30
- Last updated by the study team
- 2020-07-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Activmed Practices & Research, Inc. — Methuen, Massachusetts, United States
- AccuMed research associates — Garden City, New York, United States
Full record on ClinicalTrials.gov
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