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

What is this study about? This study tests a new robotic technology to take tissue samples from lung nodules (small spots in the lungs). Some lung nodules are cancer, but doctors need a tissue sample to know for sure. What is the problem? Current methods to get tissue from lung nodules only work about 7 out of 10 times. When they don't work, doctors may need riskier procedures. What is the new technology? The new technology is called robotic bronchoscopy (ssRAB). It uses a robot with special sensors to guide a thin tube more accurately to lung nodules than current methods. Who can join? Adults aged 19 or older who have lung nodules that need tissue sampling and are healthy enough for the procedure. What happens? Participants will have the robotic procedure while asleep under anesthesia. The robot guides a thin tube to the lung nodule to take a small tissue sample. Participants are watched for problems and followed for 6 months. What are the risks and benefits? The new technology may be more accurate and safer than current methods. The main risks are small chance of lung collapse or bleeding, similar to regular procedures. Why is this important? This study will show if the new robotic technology works well and is safe in Korea. If successful, it could help diagnose lung cancer earlier and more accurately. This study will include 100 people at Ulsan University Hospital in Korea.

NCT Number	NCT07057648
Lead Sponsor	Ulsan University Hospital
Conditions	Lung Nodules, Peripheral Lung Lesions, Pulmonary Nodules, Lung Cancers, Bronchoscopy
Enrollment	100 participants
Start Date	2025-07-09
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-13