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(for at least one location)
Jacksonville, FL
Describes the nature of a clinical study. Types include:
The purpose of this study is to assess the safety and efficacy of the Apreo BREATHE System when used to support native airways and regional release of trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to pulmonary hyperinflation despite optimal medical management.
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Open for enrollment
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.The study includes four arms based on biopsy location and biopsy modality/tool:1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)