ACR | LAB Urine Analysis Test System Evaluation of Performance

• Sponsor: Healthy.io Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04466501
• Collaborator: (none)
• Enrollment: 375
• Locations: 3
• Arm: 1
• Actual Duration (Months): 3
• Patients Per Site: 125
• Patients Per Site Per Month: 41.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Hypertension	Device: ACR LAB	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 375 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
• Actual Study Start Date: Jun 30, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACR LAB for Professional User	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.

Outcome Measures

Primary Outcome Measures

1. Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users. [11 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
2	Central Kentucky Research Associates	Lexington	Kentucky	United States	40509
3	AccuMed research associates	Garden City	New York	United States	11530

Sponsors and Collaborators

• Healthy.io Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Healthy.io Ltd.
• ClinicalTrials.gov Identifier: NCT04466501
• Other Study ID Numbers: CTP-ACR | LAB-MC-02
• First Posted: Jul 10, 2020
• Last Update Posted: Jul 10, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 10, 2020