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

NCT ID: NCT04371159

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2020-05-30

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 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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Velieve U.S.

Each participant will test their urine sample using the Velieve U.S. device

Group Type: EXPERIMENTAL

Velieve U.S.

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy.io Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

CTP-Velieve-MC-02

Identifier Type: -

Identifier Source: org_study_id