Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion™ Endoluminal System

Autor: Michael J. Simoff, Michael A. Pritchett, Janani S. Reisenauer, David E. Ost, Adnan Majid, Colleen Keyes, Roberto F. Casal, Mihir S. Parikh, Javier Diaz-Mendoza, Sebastian Fernandez-Bussy, Erik E. Folch
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: BMC Pulmonary Medicine, Vol 21, Iss 1, Pp 1-13 (2021)
Druh dokumentu: article
ISSN: 1471-2466
DOI: 10.1186/s12890-021-01693-2
Popis: Abstract Background Traditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists’ initial experience? Methods The lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median/interquartile range (IQR). Results Sixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were
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