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

Not yet recruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

July 9, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

May 31, 2027

Conditions
Lung NodulesPeripheral Lung LesionsPulmonary NodulesLung CancersBronchoscopy
Interventions
DEVICE

Shape-sensing Robotic-assisted Bronchoscopy (ssRAB)

"Diagnostic procedure using the ION endoluminal system (Intuitive Surgical, Sunnyvale, CA) for navigation and tissue sampling of peripheral pulmonary nodules. The procedure involves:~1. Pre-procedure 3D navigation planning using thin-section chest CT~2. Shape-sensing catheter navigation to target nodules~3. Real-time position monitoring with fiber optic sensors~4. Tissue sampling using various tools (biopsy needles, forceps, brush, or cryobiopsy)~5. Optional radial endobronchial ultrasound (rEBUS) confirmation~6. Fluoroscopic guidance when needed~The procedure is performed under deep sedation or general anesthesia through an endotracheal tube."

Trial Locations (1)

44033

Ulsan University Hospital, Ulsan

All Listed Sponsors
lead

Ulsan University Hospital

OTHER