A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System

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 environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.

The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Device: Velieve U.S.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Velieve U.S.; Each participant will test their urine sample using the Velieve U.S. device	Device: Velieve U.S.; The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device. The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the % agreement of the Velieve U.S., tested by the lay user, as compared to a comparator device, tested by a professional user.	11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.	11 months

Collaborators and Investigators

• Sponsor: Healthy.io Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: CTP-Velieve-MC-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No