NCT07136961

Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules

Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.

Conditions

• Lung Nodules
• Biopsy
• Navigation, Spatial

Interventions

Type	Name	Description
PROCEDURE	Robot-Assisted Bronchoscopy (RAB)	1. Preoxygenation \& Navigation Registration 2. Robotic-Guided Navigation 3. Puncture Tunnel Establishment 4. Position Verification \& Adjustment Perform confirmatory CT scan to assess tool-nodule relationship: Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule * 4mm deviation : Proceed to biopsy \>4mm deviation : Adjust based on operator judgment 5. Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps 6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift

Timeline

• Start date: 2024-12-28
• Primary completion: 2025-07-08
• Completion: 2025-10-08
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: China