Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study

Inclusion Criteria:

   - 18 years or older

   - T1 or T2 malignant oropharyngeal tumor

   - Tumor amenable to transoral resection

   - No previous treatment for the index tumor

   - Willing and able to provide written informed consent

   - Willing and able to comply with the study protocol requirements

Exclusion Criteria:

   - T3 or T4 stage tumor

   - Previous radiation treatment to the head and neck, with or without chemotherapy

   - Evidence of other primary cancers or distant metastasis or subject with synchronous
   primary tumor excluding skin cancers

   - Pre-operative expectation of needing microvascular soft-tissue reconstruction

   - Tumor that invades and/or abuts the internal and/or external carotid artery

   - Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior
   pharyngeal wall cancer

   - Evidence of mandibular invasion of tumor

   - Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2

   - On a medication that interferes with clotting that cannot be stopped prior to surgery

   - Contraindication for general anesthesia or surgery

   - Mentally handicapped or has psychological disorder or severe systemic illness that
   would preclude compliance with study requirements or ability to provide informed
   consent

   - Pregnant or suspected to be pregnant