Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands

NCT05838872 | Completed FDA Device

• 1 other identifier: ACR-US-MCU-SUP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Albuminuria; Chronic Kidney Diseases; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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).

  10 months

Secondary Outcomes (1)

• Usability Evaluation: User Performance Analysis

  10 months

Study Arms (1)

Minuteful - Kidney Urine Analysis Test System

EXPERIMENTAL

Device: Minuteful - Kidney Urine Analysis Test System

Interventions

Minuteful - Kidney Urine Analysis Test System DEVICE

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.

Also known as: Minuteful - Kidney, Minuteful - Kidney Test Device, ACR | U.S. Urine Analysis Test System

Minuteful - Kidney Urine Analysis Test System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healthy.io Ltd.: lead

Study Sites (1)

AccuMed research associates

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Albuminuria; Renal Insufficiency, Chronic; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 3, 2023
• Study Start: December 9, 2021
• Primary Completion: February 28, 2022
• Study Completion: July 15, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)