Abstract | 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.
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Authors | David I K Fielding, Farzad Bashirzadeh, Jung Hwa Son, Maryann Todman, Adrian Chin, Lionel Tan, Karin Steinke, Morgan N Windsor, Arthur Wai Sung |
Journal | Respiration; international review of thoracic diseases
(Respiration)
2019
Vol. 98
Issue 2
Pg. 142-150
ISSN: 1423-0356 [Electronic] Switzerland |
PMID | 31352444
(Publication Type: Journal Article)
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Copyright | © 2019 S. Karger AG, Basel. |
Topics |
- Adult
- Aged
- Bronchoscopy
(instrumentation, methods)
- Endoscopic Ultrasound-Guided Fine Needle Aspiration
- Endosonography
- Female
- Fiber Optic Technology
- Humans
- Image-Guided Biopsy
(instrumentation, methods)
- Lung Diseases
(diagnosis, pathology)
- Lung Neoplasms
(diagnosis, pathology)
- Male
- Middle Aged
- Pneumothorax
(epidemiology)
- Postoperative Complications
(epidemiology)
- Postoperative Hemorrhage
(epidemiology)
- Prospective Studies
- Robotic Surgical Procedures
(instrumentation, methods)
- Solitary Pulmonary Nodule
(pathology)
- Tomography, X-Ray Computed
- Tumor Burden
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