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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACR | U.S. Urine Analysis Test System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACR | U.S. Urine Analysis Test System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Males and Females 18-80 years of age.
Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
or, subjects who are healthy or pregnant.
Subject is familiar with the use of a smartphone.
Subject is capable of comprehending and following instructions in English.
Subject has facility with both hands.
Subject is capable and willing to adhere to the study procedures.
Subject is capable and willing to provide informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AccuMed research associates | Garden City | New York | 11530 | United States | ||
| PMG Research of Charleston |
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The study enrolled 250 subjects who met the inclusion criteria and performed a total of 546 tests at two U.S. clinical sites
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| ID | Title | Description |
|---|---|---|
| FG000 | ACR | U.S. Urine Analysis Test System | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACR | U.S. Urine Analysis Test System | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Each study participant was asked to perform the test twice: first, by using their preferred platform device (iOS or Android), in which usability and accuracy were evaluated; and secondly by using the other platform device, which was assessed for accuracy only. In addition, 23 spiked samples were used in order to achieve sufficient sample sizes for all analyte blocks, each sample on both platforms as well. | Posted | Count of Units | Tests | 2 months | Tests | Tests |
|
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.
The definitions are not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACR | U.S. Urine Analysis Test System | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle Jeddah (Director of Clinical Development) OR Jennifer Kachel Acobas (Director of RA) | Healthy.io | 0543111050, 0528345562 | danielle.jeddah@healthy.io, jennifer.acobas@healthy.io |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 | Aug 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| URiSCAN Optima Urine Analyzer | Device | 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. |
|
| 2 months |
| Charleston |
| South Carolina |
| 29464 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education Attainment | Count of Participants | Participants |
|
| Medical Background | Numerous subjects participating in the study were diagnosed with more than one disease, therefore numbers add up to more than 100%. | Count of Participants | Participants |
|
| Concomitant Medications | A list of concomitant medications taken by study participants was collected, including the medication name, dosage, route of administration, frequency and indication. | Count of Participants | Participants |
|
| OG000 |
| ACR | U.S. Urine Analysis Test System |
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. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Overall ease of performing the test: "normal" (3 out of 5) |
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| Overall ease of performing the test: "hard" (2 out of 5) |
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| Overall ease of performing the test: "very hard" (1 out of 5) |
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| 1st understanding question: participants who answered correctly |
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| 2nd understanding question: participants who answered correctly |
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| 3rd understanding question: participants who answered correctly |
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| 4th understanding question: participants who answered correctly |
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| 5th understanding question: participants who answered correctly |
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