title: A european multicenter study evaluating the flex robotic system in transoral robotic surgery.
abstract: To evaluate the application of the Flex Robotic System in transoral robotic surgery (TORS).
  
  
  
  Multicenter, prospective, open-label, single-armed clinical study.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Essen, Essen, Germany.
authors: Stephan
authors: S
authors: Lang
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Essen, Essen, Germany.
authors: Stefan
authors: S
authors: Mattheis
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Essen, Essen, Germany.
authors: Pia
authors: P
authors: Hasskamp
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital of Mont-Godinne, Yvoir, Belgium.
authors: Georges
authors: G
authors: Lawson
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Marburg, Marburg, Germany.
authors: Christian
authors: C
authors: Güldner
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Marburg, Marburg, Germany.
authors: Magis
authors: M
authors: Mandapathil
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Ulm, Ulm, Germany.
authors: Patrick
authors: P
authors: Schuler
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Ulm, Ulm, Germany.
authors: Thomas
authors: T
authors: Hoffmann
authors: Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Ulm, Ulm, Germany.
authors: Marc
authors: M
authors: Scheithauer
authors: Department of Otorhinolaryngology-Head and Neck Surgery, Centre Hospitalier de Luxembourg, Luxembourg, Belgium.
authors: Marc
authors: M
authors: Remacle
mesh_terms: D000368:Aged; D001706:Biopsy / Q000295:instrumentation; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000473:pathology / Q000601:surgery*; D007013:Hypopharynx / Q000473:pathology / Q000601:surgery; D007818:Laryngeal Diseases / Q000473:pathology / Q000601:surgery*; D007822:Laryngeal Neoplasms / Q000473:pathology / Q000601:surgery*; D020704:Laryngoscopes; D007830:Larynx / Q000473:pathology / Q000601:surgery; D059032:Learning Curve; D008297:Male; D008875:Middle Aged; D009959:Oropharyngeal Neoplasms / Q000473:pathology / Q000601:surgery*; D009960:Oropharynx / Q000473:pathology / Q000601:surgery; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D065287:Robotic Surgical Procedures / Q000193:education / Q000295:instrumentation*
keywords: Transoral robotic surgery; endoscope; flexible; head and neck tumors; laser; robot; robotic scope