ACR | LAB Urine Analysis Test System Evaluation of Performance
A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
1 other identifier
interventional
375
1 country
3
Brief Summary
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm. The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jun 2019
Shorter than P25 for not_applicable diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedJuly 10, 2020
July 1, 2020
3 months
July 1, 2020
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
11 months
Study Arms (1)
ACR LAB for Professional User
EXPERIMENTALInterventions
The ACR \| LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Eligibility Criteria
You may qualify if:
- 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 albumin:
- Diabetes Type I/Type II,
- Hypertension,
- Any kidney disease,
- Other relevant conditions.
- Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthy.io Ltd.lead
Study Sites (3)
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
AccuMed research associates
Garden City, New York, 11530, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 10, 2020
Study Start
June 30, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
July 10, 2020
Record last verified: 2020-07