ACR | LAB Urine Analysis Test System Evaluation of Performance
NCT ID: NCT04466501
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
375 participants
INTERVENTIONAL
2019-06-30
2019-09-30
Brief Summary
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The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ACR LAB for Professional User
ACR LAB
The ACR \| LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Interventions
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ACR LAB
The ACR \| LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Eligibility Criteria
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Inclusion Criteria
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
* Diabetes Type I/Type II,
* Hypertension,
* Any kidney disease,
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Healthy.io Ltd.
INDUSTRY
Responsible Party
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Locations
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Atlanta Center for Medical Research
Atlanta, Georgia, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
AccuMed research associates
Garden City, New York, United States
Countries
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Other Identifiers
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CTP-ACR | LAB-MC-02
Identifier Type: -
Identifier Source: org_study_id
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