A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Healthy.io Ltd.
- Enrollment
- 429
- Locations
- 3
- Primary Endpoint
- Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Dip Home-Based Dipstick Analyzer
Each participant will test their urine sample using the HBDA. device
Intervention: Dip Home-Based Dipstick Analyzer (Diagnostic Test)
Dip Home-Based Dipstick Analyzer
Each participant will test their urine sample using the HBDA. device
Intervention: Urine analysis predicate device for professional user (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.(11 months)