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Validation 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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anemia focused on measuring Smartphone app, Artificial intelligence, Public health

Eligibility Criteria

3 Years - 87 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 4, 2022
Last Updated
August 4, 2022
Sponsor
Sun Yat-sen University
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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

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Validation of a Smartphone App for Anemia Screening Among General Population

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