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

NCT04466774 | Completed FDA Device

• 1 other identifier: CTP-Healthy.io-01
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 3

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.

Conditions

Urine Detectable Acute and Chronic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.

  11 months

Study Arms (1)

Dip Home-Based Dipstick Analyzer

EXPERIMENTAL

Each participant will test their urine sample using the HBDA. device

Diagnostic Test: Dip Home-Based Dipstick Analyzer; Device: Urine analysis predicate device for professional user

Interventions

Dip Home-Based Dipstick Analyzer DIAGNOSTIC_TEST

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.

Dip Home-Based Dipstick Analyzer

Urine analysis predicate device for professional user DEVICE

Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.

Dip Home-Based Dipstick Analyzer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Healthy.io Ltd.: lead

Study Sites (3)

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Activmed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

AccuMed research associates

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: March 5, 2017
• Primary Completion: July 30, 2017
• Study Completion: September 30, 2017
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (3)