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Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial

NCT06686251 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1470

Last updated 2026-02-02

No results posted yet for this study

Summary

This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used.

The clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.

Conditions

  • Consolidation
  • Lung Injury
  • Pleural Effusion
  • Pneumothorax
  • Cardiomegaly
  • Edema Lung

Interventions

DEVICE

App LuAna

Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Joselisa Paiva, PhD · Hospital Israelita Albert Einstein

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-06-30
Completion
2026-12-01

Countries

  • Brazil

Study Locations

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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 NCT06686251 on ClinicalTrials.gov