Status:
COMPLETED
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Lead Sponsor:
Healthy.io Ltd.
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environm...
Eligibility Criteria
Inclusion
- Males and Females 18-80 years of age;
- Subjects who are healthy or:
- Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):
- Urinary tract infection (UTI)
- Patients with suspected or known occult blood in urine
- Pregnant women
- 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.
- Subject is familiar with the use of a smartphone
- Subject is capable of comprehending and following instructions in English
Exclusion
- Subject has dementia.
- Subject has mental disorders.
- Subject cannot collect urine in a receptacle.
- Subject is visually impaired (cannot read the user manual).
- Any additional reason the study physician believes disqualifies the subject from participating in the study.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04371159
Start Date
February 5 2020
End Date
May 30 2020
Last Update
June 23 2020
Active Locations (1)
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1
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409