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A european multicenter study evaluating the flex robotic system in transoral robotic surgery
Author(s) -
Lang Stephan,
Mattheis Stefan,
Hasskamp Pia,
Lawson Georges,
Güldner Christian,
Mandapathil Magis,
Schuler Patrick,
Hoffmann Thomas,
Scheithauer Marc,
Remacle Marc
Publication year - 2017
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.26358
Subject(s) - transoral robotic surgery , flex , robotic surgery , multicenter study , medicine , computer science , surgery , randomized controlled trial , telecommunications
Objectives/Hypothesis To evaluate the application of the Flex Robotic System in transoral robotic surgery (TORS). Study Design Multicenter, prospective, open‐label, single‐armed clinical study. Methods A prospective clinical follow‐up multicenter study was performed from July 2014 to October 2015 assessing the safety and efficacy of the Medrobotics Flex Robotic System for access and visualization of the oropharynx, hypopharynx, and larynx as well as for resection of benign and malignant lesions. A total of 80 patients were enrolled. Access and visualization of five anatomic subsites (base of tongue, palatine tonsil area, epiglottis, posterior pharyngeal wall, and false vocal cords) were individually graded by the surgeon. Setup times, access and visualization times, surgical results, and adverse events were documented. Results The relevant anatomic structures could be exposed and visualized properly in 75 patients, who went on to have a surgical procedure performed with the Flex Robotic System. Access and visualization of the palatine tonsil area, posterior pharyngeal wall, epiglottis, and posterior pharyngeal wall were excellent. However, false vocal cords and vocal cords were more difficult to expose. Seventy‐two patients were treated successfully with the Flex Robotic System. There were no serious or unanticipated device‐related adverse events caused by the Flex Robotic System. Conclusions Lesions in the oropharynx, hypopharynx, and larynx could be successfully resected with the Flex Robotic System, specifically developed for TORS. Our study provides evidence that the Flex Robotic System is a safe and effective tool in TORS. Laryngoscope , 2016 127:391–395, 2017