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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 is a NA study that has completed, run by Healthy.io. The registered enrollment target is 250 participants.
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".
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04626271
The ClinicalTrials.gov registry entry for NCT04626271 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Healthy.io, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ACR | U.S. Urine Analysis Test System is the first listed.
NCT04626271 reports 0 study locations.
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.
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