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

March 14, 2016 updated by: Medrobotics Corporation

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Yvoir, Belgium, 5530
        • University Hospital of Louvain at Mont-Godinne
  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89075
        • University Hospital Ulm
    • Baldingerstraße
      • Marburg, Baldingerstraße, Germany, 35043
        • University Hosptial Giessen and Marburg
    • Hufelandstraße
      • Essen, Hufelandstraße, Germany, 45147
        • University Hospital of Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects ≥ 22 years of age requiring transoral procedures

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transoral Visualization & Access
Subjects ≥ 22 yrs requiring transoral procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intra-Operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medrobotics Corporation

Investigators

  • Study Director: Michael D Tricoli, BS, MBA, Medrobotics Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLX-ENT-PMK-OUS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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