A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer

NACompletedINTERVENTIONAL
Enrollment

429

Participants

Timeline

Start Date

March 5, 2017

Primary Completion Date

July 30, 2017

Study Completion Date

September 30, 2017

Conditions
Urine Detectable Acute and Chronic Diseases
Interventions
DIAGNOSTIC_TEST

Dip Home-Based Dipstick Analyzer

The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.

DEVICE

Urine analysis predicate device for professional user

Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.

Trial Locations (3)

11530

AccuMed research associates, Garden City

30331

Atlanta Center for Medical Research, Atlanta

01844

Activmed Practices & Research, Inc., Methuen

All Listed Sponsors
lead

Healthy.io Ltd.

INDUSTRY

NCT04466774 - A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer | Biotech Hunter | Biotech Hunter