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The Galaxy System is currently the only robotic bronchoscopy system that has integrated Tool-in-Lesion-Tomosynthesis (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,3 further validation of performance (safety and efficacy) in human clinical trials was needed. It is hypothesized that integrating TiLT+ Technology may further improve yield.

Saghaie T, Williamson JP, Phillips M, Kafili D, Sundar S, Hogarth DK, et al. First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study. Respirology. 2024;29(11):969–75.

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.

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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% (strict) to 94.7% (intermediate) diagnostic yield within the study population4.

 

*Based on the strict and intermediate definitions proposed by Vachani et al.
Under the strict method, diagnostic yield is determined by specific malignant or benign diagnoses available at the time of the index bronchoscopy, with non-diagnostic (ND) and non-specific benign (NSB) results excluded, consistent with the latest ATS/ACCP strict definition.
In the intermediate method, follow-up data for cases with NSB diagnosis are incorporated. NSB findings are categorized as true negatives only when a subsequent biopsy or repeat imaging confirms their non-malignant nature. ND cases are not counted as true negatives regardless of subsequent imaging or biopsy.

 

3 Vachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The impact of alternative approaches to diagnostic yield calculation in studies of bronchoscopy. Chest. 2022 May;161(5):1426–8. Bhadra K, Rickman OB, Mahajan AK, Hogarth DK.

4 "Tool-in-lesion" accuracy of galaxy system-a robotic electromagnetic navigation BroncHoscopy with integrated tool-in-lesion-Tomosynthesis technology: the MATCH study. J Bronchology Interv Pulmonol. 2024 Jan 1;31(1):23-29.