Back to resultsEvaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
Primary Purpose
Albuminuria, Chronic Kidney Diseases, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minuteful - Kidney Urine Analysis Test System
Sponsored by
About this trial
This is an interventional diagnostic trial for Albuminuria
Eligibility Criteria
Inclusion Criteria: A) Males and Females 18-80 years of age B) Subjects with a known, well-established medical condition and/or risk factor for kidney damage, that can potentially present as an abnormal concentration of urine albumin: Diabetes (Type I/Type II, or Gestational Diabetes) High Blood Pressure (i.e., Hypertension) Cardiovascular Diseases Family History of Kidney Disease History of Acute Kidney Injury (AKI) C) Or; subjects with other medical conditions and/or risk factors that impact kidney function: Dyslipidemia Heavy smoking Obesity Inherited kidney disease (e.g. Polycystic kidney disease) Prolonged obstruction of the urinary tract from different conditions (e.g. enlarged prostate) Malignancies Recurrent kidney infections Other relevant conditions D) Subjects who are able to use both hands E) Subjects who are familiar with the use of a smartphone F) Subjects who are capable of comprehending and following instructions in English Exclusion Criteria: A) Subjects with a major cognitive impairment (e.g.: dementia, memory loss, severe mental disorder) B) Subjects who are not able to collect urine in a receptacle C) Subjects who are visually impaired (i.e., cannot read the user manual) D) Any additional reason that disqualifies the subject from participating in the study according to the study physician
Sites / Locations
- AccuMed research associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Minuteful - Kidney Urine Analysis Test System
Arm Description
Outcomes
Primary Outcome Measures
Accuracy Evaluation: The Degree of Agreement (%) of the Minuteful - Kidney 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 Minuteful - kidney test (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).
Secondary Outcome Measures
Usability Evaluation: User Performance Analysis
The usability of the Minuteful - Kidney Urine Analysis Test System will be 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
1. Study Identification
Unique Protocol Identification Number
NCT05838872
Brief Title
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
Official Title
Comparative, Controlled Study to Evaluate the Clinical Accuracy and Usability Performance of the Minuteful - Kidney Urine Analysis Test System Conducted by Lay Users
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
July 15, 2022 (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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271).
This method comparison and usability study was designed to evaluate the agreement levels of the Minuteful - Kidney Test with the comparator device (URiSCAN Optima) as well as the device's usability including the lay user's ability to understand and implement the device instructions. It also evaluates the ease of use of the device under actual use conditions in a simulated home environment.
Detailed Description
Eligible subjects meeting the inclusion criteria were recruited at the designated site by the study personnel. Following subject consent, the Minuteful - Kidney test kit, in its original packaging, along with the Minuteful - Kidney smartphone application were provided to the subject in a simulated home- use environment. All subjects were requested to follow the in-app instructions to complete the test, without any guidance from the study staff before, during or after testing. After each subject completed the test, the urine sample was tested by a professional user at the clinical site on the URiSCAN Optima device. Each urine sample was tested twice: once using the Minuteful - kidney test by the lay user and once using the comparator device (URiSCAN Optina) by the professional user.
To evaluate the usability of the device, study staff on-site were asked to observe and document the user performance on key tasks in the study flow as well as information regarding the user behavior while performing the test. Subjects were also asked to answer a usability post-test questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minuteful - Kidney Urine Analysis Test System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Minuteful - Kidney Urine Analysis Test System
Other Intervention Name(s)
Minuteful - Kidney, Minuteful - Kidney Test Device, ACR | U.S. Urine Analysis Test System
Intervention Description
Urine samples were collected and tested by a lay user, using the Minuteful - Kidney test device. The lay user test results were compared to the results obtained by testing the same urine sample on the comparison device, the URiSCAN Optima.
Primary Outcome Measure Information:
Title
Accuracy Evaluation: The Degree of Agreement (%) of the Minuteful - Kidney 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 Minuteful - kidney test (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).
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Usability Evaluation: User Performance Analysis
Description
The usability of the Minuteful - Kidney Urine Analysis Test System will be 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
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A) Males and Females 18-80 years of age
B) Subjects with a known, well-established medical condition and/or risk factor for kidney damage, that can potentially present as an abnormal concentration of urine albumin:
Diabetes (Type I/Type II, or Gestational Diabetes)
High Blood Pressure (i.e., Hypertension)
Cardiovascular Diseases
Family History of Kidney Disease
History of Acute Kidney Injury (AKI)
C) Or; subjects with other medical conditions and/or risk factors that impact kidney function:
Dyslipidemia
Heavy smoking
Obesity
Inherited kidney disease (e.g. Polycystic kidney disease)
Prolonged obstruction of the urinary tract from different conditions (e.g. enlarged prostate)
Malignancies
Recurrent kidney infections
Other relevant conditions
D) Subjects who are able to use both hands
E) Subjects who are familiar with the use of a smartphone
F) Subjects who are capable of comprehending and following instructions in English
Exclusion Criteria:
A) Subjects with a major cognitive impairment (e.g.: dementia, memory loss, severe mental disorder)
B) Subjects who are not able to collect urine in a receptacle
C) Subjects who are visually impaired (i.e., cannot read the user manual)
D) Any additional reason that disqualifies the subject from participating in the study according to the study physician
Facility Information:
Facility Name
AccuMed research associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
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