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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371159
Recruitment Status : Suspended (Temporarily suspended due to COVID-19)
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Healthy.io Ltd.

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Device: Velieve U.S. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions. [ Time Frame: 11 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371159


Locations
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United States, Florida
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
Sponsors and Collaborators
Healthy.io Ltd.
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Responsible Party: Healthy.io Ltd.
ClinicalTrials.gov Identifier: NCT04371159    
Other Study ID Numbers: CTP-Velieve-MC-02
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases