Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
Completed · Not applicable
Conditions studied: Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
In brief
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.
Key facts
- Study ID
- NCT05838872
- Run by
- Healthy.io Ltd.
- People needed
- 216
- Starts
- 2021-12-09
- Expected to finish
- 2022-07-15
- Last updated by the study team
- 2023-05-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
- 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
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
Where it is running
- AccuMed research associates — Garden City, New York, United States
Full record on ClinicalTrials.gov
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