Non-invasive removal of the Smart tracheal occlusion device for fetal congenital diaphragmatic hernia: a single-arm, open-label, phase 1 study
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This study aimed to evaluate the effectiveness and safety of a novel non-invasive tracheal occlusion device (Smart-TO) for treating congenital diaphragmatic hernia (CDH) in fetuses, which eliminates the need for a second intervention to restore airway patency. The results demonstrated a 100% deflation rate of the device using magnetic resonance imaging, with all infants having the balloon successfully expelled from their airways at birth, indicating a significant advancement in fetal surgery for CDH. Overall, the findings suggest that the Smart-TO device is effective and safe for use in this clinical context.
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