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NCT05838872 · ClinicalTrials.gov registry record · NA
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
A NA study, sponsored by Healthy.io.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT05838872: Completed NA study, sponsored by Healthy.io.
NCT05838872 is a NA study that has completed, run by Healthy.io. The registered enrollment target is 216 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05838872, a NA study, has completed, sponsored by Healthy.io.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DEVICE Minuteful - Kidney Urine Analysis Test System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2022-07-15 |
| Phase | NA |
What the finished NCT05838872 record still lists
NCT05838872 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Minuteful - Kidney Urine Analysis Test System is the first listed.
NCT05838872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05838872 about?
NCT05838872 is a clinical study titled "Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands". 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 th...
What is the current status of trial NCT05838872?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2021-12-09. Estimated completion is 2022-07-15.
What interventions are being tested in trial NCT05838872?
The interventions under investigation include: Minuteful - Kidney Urine Analysis Test System (DEVICE).
Who is sponsoring clinical trial NCT05838872?
This trial is sponsored by Healthy.io, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05838872's enrollment target sits among peer trials
216 485th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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