Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion™...

Area of Science:

• Pulmonology
• Interventional Pulmonology
• Medical Robotics

Background:

• Traditional bronchoscopy has limitations in accessing peripheral pulmonary nodules.
• Shape-sensing robotic-assisted bronchoscopy (SSRAB) offers a novel minimally invasive approach for peripheral nodule biopsy.

Purpose of the Study:

• To evaluate the feasibility and safety of SSRAB for pulmonary nodule biopsy during initial operator experience.
• To assess the ability of SSRAB to facilitate sampling of peripheral lung nodules.

Main Methods:

• A multicenter, single-arm, prospective study evaluated the Ion Endoluminal System (SSRAB).
• Sixty subjects with peripheral pulmonary nodules underwent biopsy using SSRAB.
• Safety and procedural outcomes were descriptively analyzed during the initial learning phase.

Main Results:

• Biopsy completion rate was 97.0% for 67 targeted nodules across 6 hospitals.
• Procedures were performed safely, with no reported pneumothorax or significant airway bleeding.
• The system allowed safe navigation and biopsy acquisition in proximity to virtual nodule targets.

Conclusions:

• Initial multicenter experience suggests SSRAB can be safely leveraged by bronchoscopists for peripheral nodule biopsies.
• SSRAB demonstrates potential as a valuable tool in the management of pulmonary nodules.
• Further evaluation is warranted to establish diagnostic yield and sensitivity.