ACR | LAB Urine Analysis Test System Evaluation of Performance

Hypertension Clinical Trial

Official title:

A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466501
• Other study ID #: CTP-ACR | LAB-MC-02
• Status: Completed
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2020
• Source: Healthy.io Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Device:
• ACR LAB
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.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	AccuMed research associates	Garden City	New York
United States	Central Kentucky Research Associates	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Healthy.io Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.		11 months