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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02262247
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
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.

Condition or disease
OSA Oral Disease Oropharyngeal Neoplasms Hypopharyngeal Neoplasms

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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 : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Transoral Visualization & Access
Subjects ≥ 22 yrs requiring transoral procedures

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects ≥ 22 years of age requiring transoral procedures

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02262247

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University Hospital of Louvain at Mont-Godinne
Yvoir, Belgium, 5530
University Hospital Ulm
Ulm, Baden-Württemberg, Germany, 89075
University Hosptial Giessen and Marburg
Marburg, Baldingerstraße, Germany, 35043
University Hospital of Essen
Essen, Hufelandstraße, Germany, 45147
Sponsors and Collaborators
Medrobotics Corporation
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Study Director: Michael D Tricoli, BS, MBA Medrobotics Corp

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Responsible Party: Medrobotics Corporation Identifier: NCT02262247     History of Changes
Other Study ID Numbers: FLX-ENT-PMK-OUS-001
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medrobotics Corporation:
Endoscopic Transoral

Additional relevant MeSH terms:
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Mouth Diseases
Oropharyngeal Neoplasms
Hypopharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Otorhinolaryngologic Diseases