Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and
laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Inclusion Criteria:

- Patient must present with indications for diagnostic or therapeutic approaches for
benign and/or malignant diseases of the oral cavity or laryngopharynx (including the
neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate,
posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)

- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx
for TORS instrumentation

- Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion Criteria:

- Unexplained fever and/or untreated, active infection

- Patient pregnancy

- Previous head and neck surgery that would preclude transoral/robotic procedures. This
is at the investigator's discretion. This is not an exclusion criterion for the
non-surgical arm.

- The presence of medical conditions contraindicating general anesthesia or transoral
surgical approaches

- Inability to grant informed consent

- INTRAOPERATIVE EXCLUSION CRITERIA:

- Inability to adequately visualize anatomy to perform the diagnostic or therapeutic
surgical approach transorally