An interventional study of ACR | U.S. Urine Analysis Test System and URiSCAN Optima Urine Analyzer in Albuminuria, sponsored by Healthy.io Ltd.. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Healthy.io Ltd. · Not applicable, Interventional, and Diagnostic
Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and history.
The ACR \| U.S. kit, in its original packaging, along with the ACR \| U.S. smartphone application will be provided to the subject in a simulated home- use environment. All subjects will be provided with a list of tasks to complete, including providing a urine sample and operating the ACR \| U.S. device on 2 mobile phones. After completing the test, the lay user will complete a post-test questionnaire. The study observer will also complete a questionnaire to collect information regarding the lay users' use of the ACR \| U.S.
The device use will be compared with identified risks to determine if the percentage of failures is acceptable. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
Following the usability test performed by the lay user, the subjects' urine samples will be tested by the study staff using the comparator device. These results will be considered as the "true value".
121 studies on the registry are indexed under Albuminuria; 21 are open to participants now.
This study's enrollment of 250 is above the median of 73 across 96 interventional studies indexed under Albuminuria.
Browse Albuminuria studies →Healthy.io Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
Exclusion Criteria:
Urine samples are collected and tested by a lay user, using the new home use device. The lay user test results are compared to the results obtained by testing the same urine sample on the comparison device.
Device: ACR | U.S. Urine Analysis Test System · Device: URiSCAN Optima Urine Analyzer
Each study participant will test their urine sample using the ACR \| U.S. test device - a home-use device intended for the semi-quantitative measurement of ACR in the urine (albumin and creatinine ratio) and used to aid in the management of kidney health.
Upon completion of the test using the ACR \| U.S. device, each urine sample will be provided to a professional user for further urine analysis test using the comparator device, the URiSCAN Optima Urine Analyzer.
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of ACR \| U.S. Urine Analysis Test System (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks). Different concentrations reported by the ACR \| U.S. Urine Analysis Test System were compared with results from the comparator device.
Time frame: 2 months
Usability Evaluation: User Performance Analysis
The usability of the ACR \| U.S. Urine Analysis Test System was determined by evaluating the percentage of study subjects able to perform all required steps and successfully complete the test given only the instructions and training materials provided. In addition, each subject was asked to complete a post test questionnaire to assess the device ease of use by rating the various test steps on a scale of 1 to 5, with 5 being the easiest ("very easy") and 1 the hardest ("very hard"). This questionnaire also included understanding questions in a multiple-choice, quiz-like format, to assess the participants' understanding of essential information and key test procedures in the study.
Time frame: 2 months
| Milestone | ACR | U.S. Urine Analysis Test System |
|---|---|
| Started | 250 |
| Completed | 250 |
| Not completed | 0 |
The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of ACR \| U.S. Urine Analysis Test System (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks). Different concentrations reported by the ACR \| U.S. Urine Analysis Test System were compared with results from the comparator device.
| Tests | ACR | U.S. Urine Analysis Test System |
|---|---|
| Overall - ACR Exact Agreement | 506 |
| Overall - ACR ± Block Match | 546 |
| Overall - Albumin Exact Agreement | 497 |
| Overall - Albumin ± Block Match | 546 |
| Overall - Creatinine Exact Agreement | 484 |
| Overall - Creatinine ± Block Match | 546 |
The usability of the ACR \| U.S. Urine Analysis Test System was determined by evaluating the percentage of study subjects able to perform all required steps and successfully complete the test given only the instructions and training materials provided. In addition, each subject was asked to complete a post test questionnaire to assess the device ease of use by rating the various test steps on a scale of 1 to 5, with 5 being the easiest ("very easy") and 1 the hardest ("very hard"). This questionnaire also included understanding questions in a multiple-choice, quiz-like format, to assess the participants' understanding of essential information and key test procedures in the study.
| Participants | ACR | U.S. Urine Analysis Test System |
|---|---|
| Participants able to complete the device related tasks on 1st attempt | 250 |
| Overall ease of performing the test: "very easy" (5 out of 5) | 241 |
| Overall ease of performing the test: "easy" (4 out of 5) | 9 |
| Overall ease of performing the test: "normal" (3 out of 5) | 0 |
| Overall ease of performing the test: "hard" (2 out of 5) | 0 |
| Overall ease of performing the test: "very hard" (1 out of 5) | 0 |
| 1st understanding question: participants who answered correctly | 241 |
| 2nd understanding question: participants who answered correctly | 250 |
| 3rd understanding question: participants who answered correctly | 240 |
| 4th understanding question: participants who answered correctly | 249 |
| 5th understanding question: participants who answered correctly | 250 |
Collected over Up to 1 day for each patient. Monitoring of adverse events begun after the Informed Consent Form was signed and the first study-related procedure was performed and continued until the last study-related procedure was performed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACR | U.S. Urine Analysis Test System | 0/250 (0%) | 0/250 (0%) | 0/250 (0%) |
| Age, Continuous(years) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Median | 57 ± 17.43 |
| Sex: Female, Male(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Female | 139 |
| Male | 111 |
| Ethnicity (NIH/OMB)(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 241 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 52 |
| White | 188 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Education Attainment(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Less than 9 years of education | 1 |
| 9 to 12 years of education | 27 |
| Over 12 years of education | 221 |
| Unknown | 1 |
| Medical Background(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Hypertension | 96 |
| Diabetes Type II | 45 |
| Kidney disease | 6 |
| Heart disease | 8 |
| Healthy | 139 |
| Other | 1 |
| Concomitant Medications(Participants) | ACR | U.S. Urine Analysis Test System |
|---|---|
| Use of one or more Concomitant medication(s) | 149 |
| No Use of Concomitant medication(s) | 101 |
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