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

NCT04626271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-05-09

Study results available
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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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Healthy.io Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2020-10-23
Completion
2020-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626271 on ClinicalTrials.gov