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ACR | LAB Urine Analysis Test System Evaluation of Performance

Primary Purpose

Diabetes, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACR LAB
Sponsored by
Healthy.io Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Atlanta Center for Medical Research
  • Central Kentucky Research Associates
  • AccuMed research associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACR LAB for Professional User

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2020
Last Updated
July 7, 2020
Sponsor
Healthy.io Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04466501
Brief Title
ACR | LAB Urine Analysis Test System Evaluation of Performance
Official Title
A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthy.io Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACR LAB for Professional User
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ACR LAB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
AccuMed research associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ACR | LAB Urine Analysis Test System Evaluation of Performance

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