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

Medrobotics Corporation80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

OSA Oral Disease Oropharyngeal Neoplasms Hypopharyngeal Neoplasms

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

University Hospital of Louvain at Mont-Godinne

Yvoir, Belgium

University Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

University Hosptial Giessen and Marburg

Marburg, Baldingerstraße, Germany

University Hospital of Essen

Essen, Hufelandstraße, Germany

Outcomes

Primary Outcomes

Access and Visualizaton in Oropharynx, Hypopharynx and Larynx

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.

Time frame: Intra-Operative

Data from ClinicalTrials.gov

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