Status:
COMPLETED
ACR | LAB Urine Analysis Test System Evaluation of Performance
Lead Sponsor:
Healthy.io Ltd.
Conditions:
Diabetes
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Alb...
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 albumin:
- Diabetes Type I/Type II,
- Hypertension,
- Any kidney disease,
- Other relevant conditions.
- Subjects with 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.
Exclusion
Key Trial Info
Start Date :
June 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT04466501
Start Date
June 30 2019
End Date
September 30 2019
Last Update
July 10 2020
Active Locations (3)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
2
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
3
AccuMed research associates
Garden City, New York, United States, 11530