First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules

Abstract

<b><i>Background:</i></b> We tested a new, investigational robotic-assisted bronchoscope system with a remotely controlled catheter to access small peripheral bronchi with real-time driving under live visualization and distal tip articulation of the catheter. The unique catheter remains stationary once located at the biopsy position. <b><i>Objectives:</i></b> The primary objectives of this study were to evaluate the safety and feasibility of a new shape-sensing robotic bronchoscope system to bronchoscopically approach and facilitate the sampling of small peripheral pulmonary nodules of 1–3 cm. Secondary objectives included evaluating procedural characteristics and early performance trends associated with the use of the new robotic bronchoscope system. <b><i>Methods:</i></b> Subjects were enrolled according to study eligibility criteria at a single center. Navigation pathways were semi-automatically created using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi was used real time during navigation to the displayed target. An endobronchial ultrasound mini-probe was used to confirm lesion location. Flexible 19- to 23-G needles specifically designed to accommodate tight bend radii in transbronchial needle aspiration were used along with conventional biopsy tools. Enrolled subjects completed follow-up visits up to 6 months after the procedure. <b><i>Results:</i></b> The study included 29 subjects with a mean lesion size of 12.2 ± 4.2, 12.3 ± 3.3, and 11.7 ± 4.1 mm in the axial, coronal, and sagittal planes, respectively. The CT bronchus sign was absent in 41.4% of cases. In 96.6% of cases, the target was reached, and samples were obtained. No device-related adverse events and no instances of pneumothorax or excessive bleeding were observed during the procedure. Early performance trends demonstrated an overall diagnostic yield of 79.3% and a diagnostic yield for malignancy of 88%. <b><i>Conclusion:</i></b> This new robotic-assisted bronchoscope system safely navigated to very small peripheral airways under continuous visualization, and through maintenance of a static position, it provides a unique sampling capability for the biopsy of small solitary pulmonary nodules.

Bronchoscopic treatment of inoperable nonsmall cell lung cancer

“…The newest iteration of image-guided bronchoscopy is robotic bronchoscopy, where platforms that combine advanced imaging guidance techniques with automated scopes capable of reaching the periphery of the lungs are used to access lesions previously deemed out of reach of conventional bronchoscopic techniques [91]. Initial feasibility studies are promising, even when compared to advanced techniques such as EMN bronchoscopy [91][92][93][94]. Robotic and EMN bronchoscopy have traditionally been employed as diagnostic modalities, but great interest exists in leveraging these technologies to apply therapeutic modalities for patients with peripheral nodules who cannot undergo surgical resection.…”

Embracing the robotic revolution into anaesthetic practice

“…Fielding et al. used this system in their single‐arm prospective study and found a 96.6% success rate in reaching and obtaining samples from targeted pulmonary nodules, concluding that the robot‐assisted bronchoscope navigated safely to very small peripheral airways.…”

Recent developments in advanced diagnostic bronchoscopy

“…The robotic components allow controlled advancement of the catheter as well as subtle directional movements in all planes at the catheter tip. The catheter has the unique property of maintaining a single position and angulation while not being advanced, with a sufficiently large working channel (2 mm) to allow passage of biopsy instruments [52,53].…”