search
Back to results

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

Primary Purpose

Albuminuria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACR | U.S. Urine Analysis Test System
URiSCAN Optima Urine Analyzer
Sponsored by
Healthy.io Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Albuminuria

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AccuMed research associates
  • PMG Research of Charleston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACR | U.S. Urine Analysis Test System

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 25, 2020
Last Updated
April 16, 2023
Sponsor
Healthy.io Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04626271
Brief Title
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Official Title
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthy.io Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACR | U.S. Urine Analysis Test System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ACR | U.S. Urine Analysis Test System
Intervention Description
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
Intervention Name(s)
URiSCAN Optima Urine Analyzer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
Description
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
Secondary Outcome Measure Information:
Title
Usability Evaluation: User Performance Analysis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
AccuMed research associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
PMG Research of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs