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The FRONTIER
Study

First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions


Tajalli Saghaie1, Jonathan Williamson1, Martin Philips1, Dona Kafili1, Sarika Sundar1, D. Kyle Hogarth2 and Alvin Ing1
https://doi.org/10.1111/resp.14778

 

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.

frontier study

 
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.
 
 

Results

Successful Reach

Demonstrated Tool-in-Lesion

89.5%-94.7%
(Strict - Intermediate)
Diagnostic Yield*

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 population.

 

*Strict and Intermediate methods proposed by Vachani et al. were employed to report Dx yield.
Strict method purely relies on data available at time of index bronchoscopy, and excludes cases with non-diagnostic (ND) or non-specific benign (NSB) results.
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.

 

1 Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW Australia

2 University of Chicago

3 “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 D. Kyle Hogarth, MD PMID: 37072895