RecruitingNot ApplicableNCT06686251

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

Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial


Sponsor

Hospital Israelita Albert Einstein

Enrollment

1,470 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called App LuAna for people with cardiomegaly, consolidation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEApp LuAna

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


Locations(1)

FEAS Curitiba

Curitiba, Paraná, Brazil

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NCT06686251


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