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

Completed

• Conditions: OSA; Oral Disease; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms

• Registration Number: NCT02262247
• Lead Sponsor: Medrobotics Corporation

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 Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-13
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Access and Visualizaton in Oropharynx, Hypopharynx and Larynx	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.

Trial Locations

Locations (4)

University Hospital of Louvain at Mont-Godinne; 🇧🇪 Yvoir, Belgium

University Hospital Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

University Hosptial Giessen and Marburg; 🇩🇪 Marburg, Baldingerstraße, Germany

University Hospital of Essen; 🇩🇪 Essen, Hufelandstraße, Germany