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

Urine Detectable Acute and Chronic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466774
• Other study ID #: CTP-Healthy.io-01
• Status: Completed
• Phase: N/A
• Start date: March 5, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2020
• Source: Healthy.io Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: September 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Urine Detectable Acute and Chronic Diseases

Intervention

Diagnostic Test:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	AccuMed research associates	Garden City	New York
United States	Activmed Practices & Research, Inc.	Methuen	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Healthy.io Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.		11 months