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Multicenter, Prospective Study Evaluating the Accuracy of an AI-based Smartphone Application for Non-invasive Anemia Detection

NCT07678762 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-07-01

No results posted yet for this study

Summary

Title: Multicenter, prospective study evaluating the accuracy of an AI-based smartphone application for non-invasive anemia - AnemiAI trial Short Introduction: Anemia is a common clinical condition, often underdiagnosed, with significant impact on surgical, vulnerable, and underserved populations with limited access to laboratory testing. The NiADA technology uses artificial intelligence to estimate hemoglobin levels from images of the lower palpebral conjunctiva, offering a non-invasive, rapid, and accessible alternative to conventional diagnostics. Purpose: To evaluate the diagnostic accuracy of the NiADA application for non-invasive anemia detection, compared to the standard laboratory method (venous blood draw).

Study Design: Following informed consent, participants will undergo clinical data collection and non-invasive hemoglobin estimation using the NiADA application, operated by a trained healthcare professional. The lower palpebral conjunctiva will be imaged using a compatible smartphone camera, and the app result will be recorded immediately. Within four hours of the app assessment, a venous blood sample will be collected for laboratory hemoglobin analysis, following institutional protocols. Both results - from the app and laboratory - will be recorded on the REDCap platform. Additionally, patients will complete a brief acceptability questionnaire. Execution time, technical errors, and task completion rates will also be monitored. All centers will follow a standardized data collection protocol to ensure methodological consistency and data integrity. Study Population Sample Size (n) Adult patients (≥18 years), hospitalized or in outpatient care, with a clinical request for hemoglobin testing.

Inclusion Criteria Age ≥18 years Any gender or ethnicity Clinical indication for venous hemoglobin testing

Conditions

Interventions

DEVICE

AnemIA App

Detection of Anemia using an AI App

Sponsors & Collaborators

  • Fabio Biscegli Jatene

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678762 on ClinicalTrials.gov