An interventional study of App LuAna in Consolidation, Lung Injury and Pleural Effusion, sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Other
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.
Imaging diagnostic aid tools that use AI and facilitate the identification of findings on chest x-rays can contribute to doctors' care routines and clinicians' and radiologists' reporting routines, as these tools can allow the organization of care queues according to priorities, in addition to identifying subtle findings on the image, thereby reducing errors in reading the RXT and benefiting patients with greater agility in care and a shorter time until diagnosis. However, for reliability, these tools must undergo rigorous validation processes in large populations before implementation.
114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 62 across 75 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
feedback of the artificial intelligence after the inclusion image in app LuAna.
Device: App LuAna
Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.
Detection rate
Detection rate of "Radiological Findings", before and after Artificial Intelligence assistance, compared to gold standard (report validated twice by thoracic radiologists blind to the interpretation of the examining physician and AI result).
Time frame: through study completion, an average of 1 year
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.
Of 28 interventional studies with no phase under Lung Injury, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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