NCT02973178

Scanadu Urine Device Validation Study Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Scanadu, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will test Scanadu Urine Device for clinical performance and usability.

Detailed description

The objectives of this study are to: * Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). * Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. * Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Conditions

• Urinary Tract Infections
• Proteinuria
• Ketone Urine
• Hematuria
• Glucose Intolerance

Interventions

Type	Name	Description
DEVICE	Scanadu Urine Device	Device to allow lay user to perform urinalysis test at home.

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-11-25
• Last updated: 2016-11-25

Locations

2 sites across 1 country: United States