Dip Home-Based Dipstick Analyzer Performance Evaluation

Healthy.io

Status: Completed

Conditions: Urine Detectable Acute and Chronic Diseases

Treatments: Device: Experimental: Dip Home-Based Dipstick Analyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT04465682

Protocol CTP-Healthy.io-01

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Dip Home-Based Dipstick Analyzer

Experimental group

Description:

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

Treatment:

Device: Experimental: Dip Home-Based Dipstick Analyzer