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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 2026 → Oct 31, 2026
See other at-risk trials from Hospital Israelita Albert Einstein

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment increased: 1470 → 2400 participants
    • Primary completion pushed from Jun 2026 to Oct 31, 2026
    • Eligibility criteria expanded, about 9 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 15, 2025 to Jan 5, 2026
    v3
  3. Notable Start date: Mar 2025 to Oct 15, 2025
    • Study completion date: Dec 2026 to Dec 1, 2026
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06686251
Lead Sponsor Hospital Israelita Albert Einstein
Conditions
(from sponsor)
Consolidation, Lung Injury, Pleural Effusion, Pneumothorax, Cardiomegaly, Edema Lung
Related terms Cardiomegaly, Lung Injury, Pleural Effusion, Pneumothorax, Pulmonary Edema
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov