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

• DOI: 10.1186/s12890-021-01693-2
• Publication Date: 2021-10-16T18:22:07Z
• Authors: 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 Fernand...; Erik E. Folch
• Keywords: Interquartile range; Nodule (geology); Solitary pulmonary nodule

Traditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive nodule biopsy. We sought answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists' initial experience?The lead-in stage multicenter, single-arm, prospective evaluation Ion System (PRECIsE) described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence one or more solid semi-solid 1.0 ≤ 3.5 cm in greatest dimension and any part lung. Subjects were followed at 10- 30-days post-procedure. This provided investigators staff their first human experience with system; safety procedure outcomes analyzed descriptively. Neither diagnostic yield nor sensitivity malignancy assessed this stage. Categorical variables are summarized by percentage; continuous median/interquartile range (IQR).Sixty enrolled across 6 hospitals; 67 targeted Median axial, coronal sagittal diameters < mm largest cardinal diameter 20.0 mm. Most extraluminal distance from outer edge pleura nearest fissure was 4.0 (IQR: 0.0, 15.0). bronchial generation count target location 7.0 6.0, 8.0). Procedure duration (catheter-in catheter-out) 66.5 min 50.0, 85.5). Distance catheter tip closest virtual 2.0, 12.0). Biopsy completion 97.0%. No pneumothorax airway bleeding grade reported.Bronchoscopists leveraged SSRAB's functionality drive safely close proximity obtain biopsies. initial, multicenter encouraging, suggesting that may play role management Clinical Trial Registration identifier date NCT03893539; 28/03/2019.