Back to resultsValidation of a Smartphone App for Anemia Screening Among General Population
Primary Purpose
Anemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A smartphone app for anemia screening
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia focused on measuring Smartphone app, Artificial intelligence, Public health
Eligibility Criteria
Inclusion Criteria:
- Patients should be aware of the contents and signed for the informed consent.
Exclusion Criteria:
- Patients who underwent ophthalmic or fingernail surgery in the past 30 days
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eligible patients for app-based anemia screening
Arm Description
Device: A smartphone app for anemia screening This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.
Outcomes
Primary Outcome Measures
The proportion of accurate, mistaken and missed detection of this smartphone app.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05490823
Brief Title
Validation of a Smartphone App for Anemia Screening Among General Population
Official Title
Validation of a Smartphone App for Anemia Screening Among General Population: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. Here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. This system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Smartphone app, Artificial intelligence, Public health
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eligible patients for app-based anemia screening
Arm Type
Experimental
Arm Description
Device: A smartphone app for anemia screening This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.
Intervention Type
Device
Intervention Name(s)
A smartphone app for anemia screening
Intervention Description
This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.
Primary Outcome Measure Information:
Title
The proportion of accurate, mistaken and missed detection of this smartphone app.
Time Frame
27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients should be aware of the contents and signed for the informed consent.
Exclusion Criteria:
Patients who underwent ophthalmic or fingernail surgery in the past 30 days
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaohang Wu, M.D., Ph.D
Phone
8615913177657
Email
wuxiaohang_zoc@qq.com
12. IPD Sharing Statement
Learn more about this trial
Validation of a Smartphone App for Anemia Screening Among General Population
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