Shape-sensing Robotic-assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules A Prospective Cohort Study in Korea

What this Trial Is About

Researchers are evaluating a new robotic technology called shape-sensing robotic-assisted bronchoscopy (ssRAB) to take tissue samples from peripheral lung nodules, which are small spots in the lungs that can sometimes be cancerous. Current methods for sampling these nodules are successful about 70% of the time, and this study aims to see if the ssRAB technology can improve accuracy and safety in diagnosing lung nodules in Korean patients. The ssRAB procedure uses the ION endoluminal system, which has fiber optic sensors to guide a thin catheter precisely to lung nodules for tissue sampling. Before the procedure, patients have a detailed chest CT scan for 3D planning. During the procedure, performed under sedation or general anesthesia, the robot assists navigation, and tissue is collected using biopsy needles, forceps, brushes, or cryobiopsy tools. Additional tools like radial endobronchial ultrasound and fluoroscopy may confirm positioning. Participants are monitored immediately after for complications and followed for 6 months to confirm diagnoses. Participants will undergo the robotic procedure once and be observed for any immediate complications with chest imaging and clinical checks for 24 hours post-procedure. They will then have follow-up visits for 6 months to verify diagnosis accuracy, using additional imaging or procedures if needed. Researchers will measure how often the procedure provides a definitive diagnosis, navigation success, tissue sample quality, and safety outcomes. The study includes 100 adults requiring lung nodule diagnosis and lasting approximately 6 months after the procedure for each participant.

Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea