Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images - The first human study

Study objectives: To characterize the feasibility, accuracy, and safety of the superDimension/Bronchus system (SDBS) [superDimension, Ltd; Hertzliya, Israel] in navigating to previously unreachable peripheral lung lesions and obtaining biopsy, specimens. Design: Open-label, prospective, controlled clinical study. Setting: Pulmonary institute of a university-affiliated municipal hospital. Patients: Thirteen adult candidates for nonemergency bronchoscopy who gave informed consent to participate. Interventions: The patients underwent flexible bronchoscopy using the SDBS, which is based on real-time CT-guided electromagnetic navigation and is capable of reaching peripheral lung masses beyond the reach of the bronchoscope. A position sensor was used to navigate to and sample the various target lesions for biopsy. Measurements and results: Three-dimensional chest CT was followed by SDBS methodology, for marking anatomic landmarks and the target lesion on a virtual bronchoscopy screen and for sampling the lesion. The SDBS assisted in obtaining positive biopsy diagnoses in 9 of 13 cases (69%), with an average navigation accuracy of 5.7 mm. There were no SDBS-related adverse events. Conclusions: The SDBS is safe and effective in navigating to peripheral lung lesions located beyond the optic limits of a standard flexible bronchoscope.