"Tool-in-lesion" Accuracy of Galaxy System-A Robotic Electromagnetic Navigation BroncHoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study.

Abstract

Background: The Galaxy System (Noah Medical) is a novel robotic endoluminal platform using electromagnetic navigation combined with integrated tomosynthesis technology and augmented fluoroscopy. It provides intraprocedural imaging to correct computerized tomography (CT) to body divergence and novel confirmation of tool-in-lesion (TIL). The primary aim of this study was to assess the TIL accuracy of the robotic bronchoscope with integrated digital tomosynthesis and augmented fluoroscopy.

Methods: Four operators conducted the experiment using 4 pigs. Each physician performed between 4 and 6 nodule biopsies for 20 simulated lung nodules with purple dye and a radio pacifier. Using Galaxy's "Tool-in-Lesion Tomography (TOMO+)" with augmented fluoroscopy, the physician navigated to the lung nodules, and a tool (needle) was placed into the lesion. TIL was defined by the needle in the lesion determined by cone-beam CT.

Results: The lung nodule's average size was 16.3 ± 0.97 mm and was predominantly in the lower lobes (65%). All 4 operators successfully navigated to all (100%) of the lesions in an average of 3 minutes and 39 seconds. The median number of tomosynthesis sweeps was 3 and augmented fluoroscopy was utilized in most cases (17/20 or 85%). TIL after the final TOMO sweep was 95% (19/20) and tool-touch-lesion was 5% (1/20). Biopsy yielding purple pigmentation was also 100% (20/20).

Conclusion: The Galaxy System demonstrated successful digital TOMO confirmed TIL success in 95% (19/20) of lesions and tool-touch-lesion in 5% (1/20) as confirmed by cone-beam CT. Successful diagnostic yield was achieved in 100% (20/20) of lesions as confirmed by intralesional pigment acquisition.