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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia; Anemia (Diagnosis)
• Intervention / Treatment: Device: AnemIA App

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403900
      • Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age >18 years old
• Any gender or ethnicity
• Hospitalized or outpatient

Exclusion Criteria:

• Juandice or other yelid discoloration
• Severe skin hyperpigmentation
• Dressings, injuries or deformities at the analysis site
• Infections, trauma, or scarring on or near the eye
• Hemoglobinopathies
• Hemolyzed or invalidez laboratory samples
• Hemodynamically unstable or unconscious patients
• Participants with communication or comprehension difficulties
• Patients who received blood transfusion within the last 24 hours
• Use of a tropical eye medication
• Pregnant Women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hemoglobin detection; Patients will be tested both with the app and the gold standard test for anemia.	Device: AnemIA App; Detection of Anemia using an AI App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the NiADA Smartphone Application for Detection of Anemia	Sensitivity and specificity of the NiADA smartphone application for detecting anemia compared with laboratory hemoglobin measurement (g/dL), used as the reference standard.	From enrollment to completion of anemia assessment (up to 1 week)

Collaborators and Investigators

• Sponsor: Fabio Biscegli Jatene

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Artificial Inteligence; Anemia, Diagnosis, AI
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Disease; Anemia
• Other Study ID Numbers: SDC 6227/25/238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No