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

OSA Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262247
• Other study ID #: FLX-ENT-PMK-OUS-001
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: March 14, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Medrobotics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionBelgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypopharyngeal Neoplasms
• Neoplasms
• Oral Disease
• Oropharyngeal Neoplasms
• OSA

Locations

Country	Name	City	State
Belgium	University Hospital of Louvain at Mont-Godinne	Yvoir
Germany	University Hospital of Essen	Essen	Hufelandstraße
Germany	University Hosptial Giessen and Marburg	Marburg	Baldingerstraße
Germany	University Hospital Ulm	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Medrobotics Corporation

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intra-Operative	No