Urine Detectable Acute and Chronic DiseasesNCT04466774
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
A study testing Dip Home-Based Dipstick Analyzer and Urine analysis predicate device for professional user in people with Urine Detectable Acute and Chronic Diseases, run by Healthy.io Ltd. at 3 sites in United States.
Trial summary
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urine Detectable Acute and Chronic Diseases
- What is being tested?
- Dip Home-Based Dipstick Analyzer and Urine analysis predicate device for professional user
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Mar 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women 18-80 years of age
- Subjects who are healthy or pregnant; or
- Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
- Subject is capable and willing to provide informed consent.
- Subject has facility with both hands.
- Subject is capable and willing to adhere to the study procedures
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
AccuMed research associates
Garden City, New York, 11530
Activmed Practices & Research, Inc.
Methuen, Massachusetts, 01844
About this study
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board.
The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
- Being tested
- Dip Home-Based Dipstick Analyzer, Urine analysis predicate device for professional user
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dip Home-Based Dipstick AnalyzerDiagnostic test
The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Urine analysis predicate device for professional userDevice
Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
| Study group | Role | What they receive |
|---|---|---|
| Dip Home-Based Dipstick Analyzer | Experimental | Each participant will test their urine sample using the HBDA. device Receives: Diagnostic Test: Dip Home-Based Dipstick Analyzer; Device: Urine analysis predicate device for professional user |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
Measured: 11 months
Secondary outcomes (1)
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start5 Mar 2017
- Primary completion30 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Detectable Acute and Chronic DiseasesStudies 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
- 429 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
- NCT04466774
- Sponsor's protocol ID
- CTP-Healthy.io-01
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
- ClinicalTrials.gov ID
- NCT04466774
- Acronym / sponsor ID
- CTP-Healthy.io-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Healthy.io Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board.
The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dip Home-Based Dipstick Analyzer | Experimental | Diagnostic Test: Dip Home-Based Dipstick Analyzer, Device: Urine analysis predicate device for professional userEach participant will test their urine sample using the HBDA. device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women 18-80 years of age
- Subjects who are healthy or pregnant; or
- Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
- Subject is capable and willing to provide informed consent.
- Subject has facility with both hands.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dip Home-Based Dipstick AnalyzerThe Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. | Diagnostic test | Dip Home-Based Dipstick Analyzer |
| Urine analysis predicate device for professional userResults of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user. | Device | Dip Home-Based Dipstick Analyzer |
Primary outcome
Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
Time frame: 11 months
1 secondary outcome
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.
Time frame: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dip Home-Based Dipstick Analyzer and Urine analysis predicate device for professional user in people with Urine Detectable Acute and Chronic Diseases, run by Healthy.io Ltd. at 3 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 6 inclusion and 0 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user. (time frame: 11 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 10 Jul 2020.