First-in-Human Clinical Trial of the Galaxy System

The Galaxy System™ is currently the only robotic bronchoscopy system that has integrated Tool-in-Lesion-Tomography (TiLT) technology which enables real-time lesion updates supporting correction of CT-to-body divergence.
Having conducted pre-clinical studies that demonstrated satisfactory performance in safely achieving successful peripheral lung nodule biopsy,¹ further validation of performance (safety and efficacy) in human clinical trials was needed. It is hypothesized that integrating TiLT⁺ Technology™ may further improve accuracy and yield.

Study Objective: The primary objective of this study was to evaluate the safety and feasibility of using the Galaxy System to bronchoscopically biopsy small peripheral pulmonary nodules between 1-3 cm.

Study Design and Methods: A prospective single-arm feasibility study to evaluate the use of robotic EMN-guided bronchoscopy with integrated tomosynthesis technology for accessing and biopsying small peripheral pulmonary nodules (PPN).

Robotic bronchoscopy was performed under general anesthesia using electromagnetic navigation guidance with TiLT-assisted lesion sampling using a combination of transbronchial needles, forceps and cryoprobes.

Patients were followed up for up to 6 months.

Number of Patients	Number of Nodules	Average Lesion Size	Average Distance to Pleura
18	19	20 mm	11.5 mm

Conclusions: The Galaxy Robotic System with its integrated digital tomosynthesis was safe and feasible in targeting small PPNs and was able to achieve 100% tool-in-lesion and 89.5% to 94.7% diagnostic yield within the study population.

*Pending patient follow up

¹ “Tool-in-lesion” Accuracy of Galaxy System – A Robotic Electromagnetic Navigation Bronchoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study Krish Bhadra, MD, Otis B. Rickman, DO, Amit K. Mahajan, MD, and Douglas Kyle Hogarth, MD
PMID: 37072895

The FRONTIER
Study