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NCT04626271 · ClinicalTrials.gov registry record · NA
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
A NA study, sponsored by Healthy.io.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT04626271: Completed NA study, sponsored by Healthy.io.
NCT04626271 is a NA study that has completed, run by Healthy.io. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04626271, a NA study, has completed, sponsored by Healthy.io.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study 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".
Primary Outcome
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.
Interventions
- DEVICE ACR | U.S. Urine Analysis Test System
- DEVICE URiSCAN Optima Urine Analyzer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2020-10-25 |
| Phase | NA |
What the finished NCT04626271 record still lists
NCT04626271 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which ACR | U.S. Urine Analysis Test System is the first listed.
NCT04626271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04626271 about?
NCT04626271 is a clinical study titled "Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands". 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 A...
What is the current status of trial NCT04626271?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2020-08-31. Estimated completion is 2020-10-25.
What interventions are being tested in trial NCT04626271?
The interventions under investigation include: ACR | U.S. Urine Analysis Test System (DEVICE), URiSCAN Optima Urine Analyzer (DEVICE).
Who is sponsoring clinical trial NCT04626271?
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 NCT04626271's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 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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