Validation of a Smartphone App for Anemia Screening Among General Population

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05490823
Collaborator
(none)
1,000
1
1
48
20.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: A smartphone app for anemia screening
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation of a Smartphone App for Anemia Screening Among General Population: A Clinical Trial
Actual Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eligible patients for app-based anemia screening

Device: A smartphone app for anemia screening This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.

Device: A smartphone app for anemia screening
This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.

Outcome Measures

Primary Outcome Measures

  1. The proportion of accurate, mistaken and missed detection of this smartphone app. [27 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 87 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05490823
Other Study ID Numbers:
  • AnemiaApp-2021
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022