Dip Home-Based Dipstick Analyzer Performance Evaluation

Overview

The Dip Home-Based Dipstick Analyzer (henceforth HBDA) 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 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.

Full Title of Study: “A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

Interventions

  • Device: Experimental: Dip Home-Based Dipstick Analyzer
    • 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 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.

Arms, Groups and Cohorts

  • Experimental: 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 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
    • Time Frame: 11 months

Secondary Measures

  • Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions
    • Time Frame: 11 months

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women 18-80 years of age – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Healthy.io Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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