AlbuminuriaNCT04626271
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
A study testing ACR | U.S. Urine Analysis Test System and URiSCAN Optima Urine Analyzer in people with Albuminuria, run by Healthy.io Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Albuminuria
- What is being tested?
- ACR | U.S. Urine Analysis Test System and URiSCAN Optima Urine Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2020to 25 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females 18-80 years of age.
- Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
- Diabetes Type I/Type II,
- Hypertension,
- any kidney disease,
- other relevant conditions,
Show all 12Show fewer
- or, subjects who are healthy or pregnant.
- Subject is familiar with the use of a smartphone.
- Subject is capable of comprehending and following instructions in English.
- Subject has facility with both hands.
- Subject is capable and willing to adhere to the study procedures.
- Subject is capable and willing to provide informed consent.
Who cannot join
- Subject has dementia.
- Subject has severe mental disorders.
- Subject cannot collect urine in a receptacle.
- Subject is visually impaired (cannot read the user manual).
- Any additional reason the study physician believes disqualifies the subject from participating in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PMG Research of Charleston
Charleston, South Carolina, 29464
AccuMed research associates
Garden City, New York, 11530
About this study
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.
Read more
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".
- Conditions
- Albuminuria
- Being tested
- ACR | U.S. Urine Analysis Test System, URiSCAN Optima Urine Analyzer
- Medical subject headings
- Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACR | U.S. Urine Analysis Test SystemDevice
Each study participant will test their urine sample using the ACR | U.S. test device - a home-use device intended for the semi-quantitative measurement of ACR in the urine (albumin and creatinine ratio) and used to aid in the management of kidney health.
URiSCAN Optima Urine AnalyzerDevice
Upon completion of the test using the ACR | U.S. device, each urine sample will be provided to a professional user for further urine analysis test using the comparator device, the URiSCAN Optima Urine Analyzer.
| Study group | Role | What they receive |
|---|---|---|
| ACR | U.S. Urine Analysis Test System | Experimental | Urine samples are collected and tested by a lay user, using the new home use device. The lay user test results are compared to the results obtained by testing the same urine sample on the comparison device. Receives: Device: ACR | U.S. Urine Analysis Test System; Device: URiSCAN Optima Urine Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. 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 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.
Measured: 2 months
Secondary outcomes (1)
Usability Evaluation: User Performance Analysis
The usability of the ACR | U.S. Urine Analysis Test System was determined by evaluating the percentage of study subjects able to perform all required steps and successfully complete the test given only the instructions and training materials provided. In addition, each subject was asked to complete a post test questionnaire to assess the device ease of use by rating the various test steps on a scale of 1 to 5, with 5 being the easiest ("very easy") and 1 the hardest ("very hard"). This questionnaire also included understanding questions in a multiple-choice, quiz-like format, to assess the participants' understanding of essential information and key test procedures in the study.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start31 Aug 2020
- Primary completion23 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthy.io Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626271
- Sponsor's protocol ID
- ACR-US-MCU-01
- Status last verified
- Apr 2023
- First submitted
- 25 Oct 2020
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
- ClinicalTrials.gov ID
- NCT04626271
- Acronym / sponsor ID
- ACR-US-MCU-01
- Conditions
- Albuminuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Healthy.io Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACR | U.S. Urine Analysis Test System | Experimental | Device: ACR | U.S. Urine Analysis Test System, Device: URiSCAN Optima Urine AnalyzerUrine samples are collected and tested by a lay user, using the new home use device. The lay user test results are compared to the results obtained by testing the same urine sample on the comparison device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and Females 18-80 years of age.
- Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
- or, subjects who are healthy or pregnant.
- Subject is familiar with the use of a smartphone.
- Subject is capable of comprehending and following instructions in English.
Key exclusion criteria (5 listed)
- Subject has dementia.
- Subject has severe mental disorders.
- Subject cannot collect urine in a receptacle.
- Subject is visually impaired (cannot read the user manual).
- Any additional reason the study physician believes disqualifies the subject from participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACR | U.S. Urine Analysis Test SystemEach study participant will test their urine sample using the ACR | U.S. test device - a home-use device intended for the semi-quantitative measurement of ACR in the urine (albumin and creatinine ratio) and used to aid in the management of kidney health. | Device | ACR | U.S. Urine Analysis Test System |
| URiSCAN Optima Urine AnalyzerUpon completion of the test using the ACR | U.S. device, each urine sample will be provided to a professional user for further urine analysis test using the comparator device, the URiSCAN Optima Urine Analyzer. | Device | ACR | U.S. Urine Analysis Test System |
Primary outcome
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
Time frame: 2 months
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.
1 secondary outcome
Usability Evaluation: User Performance Analysis
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACR | U.S. Urine Analysis Test System and URiSCAN Optima Urine Analyzer in people with Albuminuria, run by Healthy.io Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.