Status:
COMPLETED
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Lead Sponsor:
Healthy.io Ltd.
Conditions:
Urine Detectable Acute and Chronic Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2017
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT04466774
Start Date
March 5 2017
End Date
September 30 2017
Last Update
July 10 2020
Active Locations (3)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
2
Activmed Practices & Research, Inc.
Methuen, Massachusetts, United States, 01844
3
AccuMed research associates
Garden City, New York, United States, 11530