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

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.

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Key information

Conditions

OSA Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Diseases Mouth Diseases Neoplasms Neoplasms by Site Oral Disease Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Stomatognathic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Louvain at Mont-Godinne, Yvoir, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥ 22 years of age
Candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Exclusion criteria

Less than 22 years of age
Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Medrobotics Corporation

Other

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 13, 2014
Registry last updated: Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed