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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02262247

Enrollment

Registered

2014-10-13

Start date

2014-07-31

Completion date

2015-12-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharyngeal Neoplasms, Oral Disease, Oropharyngeal Neoplasms, OSA

Keywords

Transoral, Oropharynx, Hypopharynx, Endoscopic, TORS, Endoscopic Transoral, Larynx

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium, Germany

Outcome results