Status:
COMPLETED
Healthy.io Method Comparison & User Performance Study
Lead Sponsor:
Healthy.io Ltd.
Conditions:
Urinary Tract Infection
Kidney Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objectives of the Healthy.io Method Comparison and User Performance Study are: 1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer. 2. To e...
Eligibility Criteria
Inclusion
- Subject is male or female, 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 (examples of such diseases include the following):
- diabetes Type I, Type II, or gestational diabetes (Type III) or,
- urinary tract infection (UTI)
- heart disease
- kidney disease
- liver disease
- pregnant women with preeclampsia, gestational diabetes or UTI
- any pathological findings which might be identified by the urine test (according to the physician discretion)
- 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
- Subject is familiar with the use of a smartphone.
Exclusion
- Subject has dementia.
- Subject has mental disorders.
- Subject is visually impaired (cannot read the user manual).
- Subject cannot collect urine in receptacle.
- Any other reason that might preclude the subject from the study.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT02785445
Start Date
October 1 2015
End Date
September 1 2017
Last Update
September 11 2017
Active Locations (2)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
2
AccuMed Research Associates
Garden City, New York, United States, 11530