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
| Verified date | July 2020 |
| Source | Healthy.io Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | June 30, 2018 |
| Est. primary completion date | June 30, 2018 |
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Healthy.io Ltd. |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04466774 -
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
|
N/A |