Back to resultsA Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Velieve U.S.
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Tract Infections
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.
Sites / Locations
- Comprehensive Clinical Trials, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Velieve U.S.
Arm Description
Each participant will test their urine sample using the Velieve U.S. device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04371159
Brief Title
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Official Title
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthy.io Ltd.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Velieve U.S.
Arm Type
Experimental
Arm Description
Each participant will test their urine sample using the Velieve U.S. device
Intervention Type
Device
Intervention Name(s)
Velieve U.S.
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.
Time Frame
11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
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