Clinical Trial: A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures

Brief Summary: The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

Detailed Summary:
Sponsor: Medrobotics Corporation

Current Primary Outcome: Access and Visualizaton in Oropharynx, Hypopharynx and Larynx [ Time Frame: Intra-Operative ]

Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.


Original Primary Outcome: Access and Visualization in Orophayrnx and Hypopharynx [ Time Frame: Surgical Procedure ]

Ability to access (i.e. touch with compatible flexible instruments inserted through the Flex System accessory channels) and visualize all the following anatomical locations in the oropharynx, hypopharynx, and upper region of the larynx (distal to the vocal cords) via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medrobotics Corporation

Dates:
Date Received: September 23, 2014
Date Started: July 2014
Date Completion:
Last Updated: March 14, 2016
Last Verified: March 2016