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

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ClinicalTrials.gov Identifier: NCT02262247
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : March 16, 2016
Sponsor:
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

Group/Cohort
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.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02262247


Locations
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Belgium
University Hospital of Louvain at Mont-Godinne
Yvoir, Belgium, 5530
Germany
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
Investigators
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Study Director: Michael D Tricoli, BS, MBA Medrobotics Corp

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Responsible Party: Medrobotics Corporation
ClinicalTrials.gov 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:
Transoral
Oropharynx
Hypopharynx
Endoscopic
TORS
Endoscopic Transoral
Larynx

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