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CompletedNCT02262247Updated Mar 16, 2016

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

An observational study in OSA, Oral Disease and Oropharyngeal Neoplasms, sponsored by Medrobotics Corporation. Completed at 4 sites in 2 countries. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Medrobotics Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • OSA
  • Oral Disease
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms

Keywords

  • Transoral
  • Oropharynx
  • Hypopharynx
  • Endoscopic
  • TORS
  • Endoscopic Transoral
  • Larynx
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 80 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Medrobotics Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Less than 22 years of age
  • Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Transoral Visualization & Access

    Subjects ≥ 22 yrs requiring transoral procedures

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intra-Operative

07

Study locations

4 sites
  • University Hospital of Louvain at Mont-Godinne
    Yvoir, 5530, Belgium
  • University Hospital Ulm
    Ulm, Baden-Württemberg 89075, Germany
  • University Hosptial Giessen and Marburg
    Marburg, Baldingerstraße 35043, Germany
  • University Hospital of Essen
    Essen, Hufelandstraße 45147, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02262247
Lead sponsor
Medrobotics Corporation
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Jul 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Mar 16, 2016

Study contacts

Michael D Tricoli, BS, MBA
study director · Medrobotics Corp

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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