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

NCT07678762 | Active Not Recruiting DMC

• 1 other identifier: SDC 6227/25/238
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Anemia (Diagnosis); Anemia

Keywords

Anemia, Diagnosis, AI; Artificial Inteligence

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Hemoglobin detection

ACTIVE COMPARATOR

Patients will be tested both with the app and the gold standard test for anemia.

Device: AnemIA App

Interventions

AnemIA App DEVICE

Detection of Anemia using an AI App

Hemoglobin detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fabio Biscegli Jatene: lead

Study Sites (1)

Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

MeSH Terms

Conditions

Anemia; Disease

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 1, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)