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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Velieve U.S.

Device

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.

Primary outcomes

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.

Time frame: 11 months

Secondary outcomes

Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.

Time frame: 11 months

Sponsors and collaborators

Lead sponsor

Healthy.io Ltd.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 1, 2020
Registry last updated: Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed