Back to resultsA Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Primary Purpose
Urine Detectable Acute and Chronic Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dip Home-Based Dipstick Analyzer
Urine analysis predicate device for professional user
Sponsored by
About this trial
This is an interventional diagnostic trial for Urine Detectable Acute and Chronic Diseases
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
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
Each participant will test their urine sample using the HBDA. device
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
1. Study Identification
Unique Protocol Identification Number
NCT04466774
Brief Title
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
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
March 5, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (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 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
429 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dip Home-Based Dipstick Analyzer
Arm Type
Experimental
Arm Description
Each participant will test their urine sample using the HBDA. device
Intervention Type
Diagnostic Test
Intervention Name(s)
Dip Home-Based Dipstick Analyzer
Intervention Description
The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Intervention Type
Device
Intervention Name(s)
Urine analysis predicate device for professional user
Intervention Description
Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
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
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
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