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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transoral Visualization & Access | Subjects ≥ 22 yrs requiring transoral procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-Operative |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects ≥ 22 years of age requiring transoral procedures
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Tricoli, BS, MBA | Medrobotics Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Louvain at Mont-Godinne | Yvoir | 5530 | Belgium | |||
| University Hospital Ulm |
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| Ulm |
| Baden-Wurttemberg |
| 89075 |
| Germany |
| University Hosptial Giessen and Marburg | Marburg | Baldingerstraße | 35043 | Germany |
| University Hospital of Essen | Essen | Hufelandstraße | 45147 | Germany |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012140 | Respiratory Tract Diseases |
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