4.5 Article

Early results of a safety and feasibility clinical trial of a novel single-port flexible robot for transoral robotic surgery

期刊

EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY
卷 274, 期 11, 页码 3993-3996

出版社

SPRINGER
DOI: 10.1007/s00405-017-4729-y

关键词

Flexible robot; Transoral robotic surgery; TORS; da Vinci; Clinical trial; Transoral

资金

  1. Intuitive Surgical, Inc.

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The aim of this study was to describe the early results of a phase 1 safety and feasibility clinical trial of the first clinical use of a novel robot for transoral robotic surgery (TORS)-the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA). Study design of this study is prospective clinical trial. The methods used in this study are prospective innovation, development, exploration, assessment, and long-term study phase 1 clinical trial. Early results of six patients underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) demonstrate access the nasopharynx, oropharynx, larynx, and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all six patients. The early results of this safety and feasibility trial of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) clearly demonstrate that the device is safe and that it is feasible in performing TORS to access the nasopharynx, oropharynx, larynx, and hypopharynx.

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