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

Not Applicable

Completed

• Conditions: Urine Detectable Acute and Chronic Diseases
• Interventions: Diagnostic Test: Dip Home-Based Dipstick Analyzer; Device: Urine analysis predicate device for professional user

• Registration Number: NCT04466774
• Lead Sponsor: Healthy.io Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-05
• Primary Completion: 2017-07-30
• Study Completion: 2017-09-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dip Home-Based Dipstick Analyzer	Urine analysis predicate device for professional user	Each participant will test their urine sample using the HBDA. device
Dip Home-Based Dipstick Analyzer	Dip Home-Based Dipstick Analyzer	Each participant will test their urine sample using the HBDA. device

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.	11 months

Trial Locations

Locations (3)

Activmed Practices & Research, Inc.; 🇺🇸 Methuen, Massachusetts, United States

AccuMed research associates; 🇺🇸 Garden City, New York, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States