Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands

NCT ID: NCT04626271

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2020-10-25

Brief Summary

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".

Conditions

Albuminuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ACR | U.S. Urine Analysis Test System

Intervention Type: 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.

URiSCAN Optima Urine Analyzer

Intervention Type: 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.

Interventions

ACR | U.S. Urine Analysis Test System

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.

Intervention Type: DEVICE

URiSCAN Optima Urine Analyzer

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.

Intervention Type: DEVICE

Eligibility Criteria

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:

• Diabetes Type I/Type II,
• Hypertension,
• any kidney disease,
• other relevant conditions,
• 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

• Subject has dementia.
• Subject has severe mental disorders.
• Subject cannot collect urine in a receptacle.
• Subject is visually impaired (cannot read the user manual).
• Any additional reason the study physician believes disqualifies the subject from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy.io Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AccuMed research associates

Garden City, New York, United States

PMG Research of Charleston

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ACR-US-MCU-01

Identifier Type: -

Identifier Source: org_study_id