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Dip Home-Based Dipstick Analyzer Performance Evaluation

Primary Purpose

Urine Detectable Acute and Chronic Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Dip Home-Based Dipstick Analyzer
Sponsored by
Healthy.io Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urine Detectable Acute and Chronic Diseases

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 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

Sites / Locations

  • Atlanta Center for Medical Research
  • Activmed Practices & Research, Inc.
  • AccuMed research associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dip Home-Based Dipstick Analyzer

Arm Description

The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user

Outcomes

Primary Outcome Measures

Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.

Secondary Outcome Measures

Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions

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
NCT04465682
Brief Title
Dip Home-Based Dipstick Analyzer Performance Evaluation
Official Title
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urine Detectable Acute and Chronic Diseases

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dip Home-Based Dipstick Analyzer
Arm Type
Experimental
Arm Description
The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user
Intervention Type
Device
Intervention Name(s)
Experimental: Dip Home-Based Dipstick Analyzer
Intervention Description
Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions
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 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
Facility Information:
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Activmed Practices & Research, Inc.
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
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

Dip Home-Based Dipstick Analyzer Performance Evaluation

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