The study involved 32 physicians who collected over 3,250 fresh biopsy specimens using four distinct techniques, including cryobiopsy and endobronchial ultrasound-guided needle aspiration. By utilizing the NIO Imaging System, researchers examined tissue without the need for traditional freezing or staining, allowing for rapid digital analysis that preserves the specimen for later molecular testing.
Invenio Imaging Completes Enrollment for AI-Powered Lung Cancer Study
With 1,006 patients enrolled across seven medical centers, Invenio Imaging has finalized the ON-SITE study, a pivotal clinical trial testing an AI-based module designed to provide real-time assessment of lung biopsy specimens during bronchoscopic procedures, potentially solving long-standing diagnostic bottlenecks in the operating room.
Currently, rapid on-site evaluation requires specialized pathology personnel who are not always available during procedures. Dr. Gustavo Cumbo-Nacheli, a principal investigator based in Grand Rapids, noted that while bronchoscopic technology has advanced, tissue assessment capabilities have lagged behind. The NIO Lung Cancer Reveal module, which holds FDA Breakthrough Device Designation, aims to bridge this gap by identifying cell morphology suspicious for cancer directly in the procedure suite. Invenio Imaging plans to use the data gathered from these 1,006 patients to support a future regulatory submission, though the technology remains investigational and is not yet cleared for clinical use in the United States.
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