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Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules
Sponsor: The First Affiliated Hospital of Nanchang University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-12-28
Completion Date
2025-10-08
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China