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

Sponsor

Medrobotics Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT02262247

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OSA Oral Disease Oropharyngeal Neoplasms Hypopharyngeal Neoplasms

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Transoral Visualization & Access Subjects ≥ 22 yrs requiring transoral procedures

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Louvain at Mont-Godinne	Yvoir		Belgium	5530
2	University Hospital Ulm	Ulm	Baden-Württemberg	Germany	89075
3	University Hosptial Giessen and Marburg	Marburg	Baldingerstraße	Germany	35043
4	University Hospital of Essen	Essen	Hufelandstraße	Germany	45147