BACKGROUND: We tested a new, investigational robotic-assisted bronchoscope system with a remotely controlled catheter to access small peripheral bronchi with real-time driving under live visualization and distal tip articulation of the catheter. The unique catheter remains stationary once located at the biopsy position. OBJECTIVES: The primary objectives of this study were to evaluate the safety and feasibility of a new shape-sensing robotic bronchoscope system to bronchoscopically approach and facilitate the sampling of small peripheral pulmonary nodules of 1-3 cm. Secondary objectives included evaluating procedural characteristics and early performance trends associated with the use of the new robotic bronchoscope system. METHODS: Subjects were enrolled according to study eligibility criteria at a single center. Navigation pathways were semi-automatically created using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi was used real time during navigation to the displayed target. An endobronchial ultrasound mini-probe was used to confirm lesion location. Flexible 19- to 23-G needles specifically designed to accommodate tight bend radii in transbronchial needle aspiration were used along with conventional biopsy tools. Enrolled subjects completed follow-up visits up to 6 months after the procedure. RESULTS: The study included 29 subjects with a mean lesion size of 12.2 ± 4.2, 12.3 ± 3.3, and 11.7 ± 4.1 mm in the axial, coronal, and sagittal planes, respectively. The CT bronchus sign was absent in 41.4% of cases. In 96.6% of cases, the target was reached, and samples were obtained. No device-related adverse events and no instances of pneumothorax or excessive bleeding were observed during the procedure. Early performance trends demonstrated an overall diagnostic yield of 79.3% and a diagnostic yield for malignancy of 88%. CONCLUSION: This new robotic-assisted bronchoscope system safely navigated to very small peripheral airways under continuous visualization, and through maintenance of a static position, it provides a unique sampling capability for the biopsy of small solitary pulmonary nodules.
BACKGROUND: We tested a new, investigational robotic-assisted bronchoscope system with a remotely controlled catheter to access small peripheral bronchi with real-time driving under live visualization and distal tip articulation of the catheter. The unique catheter remains stationary once located at the biopsy position. OBJECTIVES: The primary objectives of this study were to evaluate the safety and feasibility of a new shape-sensing robotic bronchoscope system to bronchoscopically approach and facilitate the sampling of small peripheral pulmonary nodules of 1-3 cm. Secondary objectives included evaluating procedural characteristics and early performance trends associated with the use of the new robotic bronchoscope system. METHODS: Subjects were enrolled according to study eligibility criteria at a single center. Navigation pathways were semi-automatically created using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi was used real time during navigation to the displayed target. An endobronchial ultrasound mini-probe was used to confirm lesion location. Flexible 19- to 23-G needles specifically designed to accommodate tight bend radii in transbronchial needle aspiration were used along with conventional biopsy tools. Enrolled subjects completed follow-up visits up to 6 months after the procedure. RESULTS: The study included 29 subjects with a mean lesion size of 12.2 ± 4.2, 12.3 ± 3.3, and 11.7 ± 4.1 mm in the axial, coronal, and sagittal planes, respectively. The CT bronchus sign was absent in 41.4% of cases. In 96.6% of cases, the target was reached, and samples were obtained. No device-related adverse events and no instances of pneumothorax or excessive bleeding were observed during the procedure. Early performance trends demonstrated an overall diagnostic yield of 79.3% and a diagnostic yield for malignancy of 88%. CONCLUSION: This new robotic-assisted bronchoscope system safely navigated to very small peripheral airways under continuous visualization, and through maintenance of a static position, it provides a unique sampling capability for the biopsy of small solitary pulmonary nodules.
Authors: Alexander C Chen; Nicholas J Pastis; Michael S Machuzak; Thomas R Gildea; Michael J Simoff; Colin T Gillespie; Amit K Mahajan; Scott S Oh; Gerard A Silvestri Journal: Respiration Date: 2019-12-05 Impact factor: 3.580
Authors: Inbar Fried; Janine Hoelscher; Mengyu Fu; Maxwell Emerson; Tayfun Efe Ertop; Margaret Rox; Josephine Granna; Alan Kuntz; Jason A Akulian; Robert J Webster; Ron Alterovitz Journal: IEEE Int Conf Robot Autom Date: 2021-10-18
Authors: Lonny Yarmus; Jason Akulian; Momen Wahidi; Alex Chen; Jennifer P Steltz; Sam L Solomon; Diana Yu; Fabien Maldonado; Jose Cardenas-Garcia; Daniela Molena; Hans Lee; Anil Vachani Journal: Chest Date: 2019-11-01 Impact factor: 9.410
Authors: Or Kalchiem-Dekel; James G Connolly; I-Hsin Lin; Bryan C Husta; Prasad S Adusumilli; Jason A Beattie; Darren J Buonocore; Joseph Dycoco; Paige Fuentes; David R Jones; Robert P Lee; Bernard J Park; Gaetano Rocco; Mohit Chawla; Matthew J Bott Journal: Chest Date: 2021-08-09 Impact factor: 9.410
Authors: Christopher M Kapp; Jason A Akulian; Diana H Yu; Alexander Chen; José Cárdenas-García; Daniela Molena; Anil Vachani; Momen M Wahidi; Fabien Maldonado; David Fielding; Lonny B Yarmus; Hans Lee Journal: ATS Sch Date: 2020-12-23