A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
NCT ID: NCT04466774
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
429 participants
INTERVENTIONAL
2017-03-05
2017-09-30
Brief Summary
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The user will also complete a questionnaire to collect information regarding the use of the HBDA 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 HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
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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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Dip Home-Based Dipstick Analyzer
Each participant will test their urine sample using the HBDA. device
Dip Home-Based Dipstick Analyzer
The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Urine analysis predicate device for professional user
Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
Interventions
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Dip Home-Based Dipstick Analyzer
The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Urine analysis predicate device for professional user
Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
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 one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
* 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
Activmed Practices & Research, Inc.
Methuen, Massachusetts, United States
AccuMed research associates
Garden City, New York, United States
Countries
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Other Identifiers
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CTP-Healthy.io-01
Identifier Type: -
Identifier Source: org_study_id
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