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

Not Recruiting

Trial ID: NCT03049280


A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

Official Title

A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors

Stanford Investigator(s)

Chris Holsinger, MD, FACS
Chris Holsinger, MD, FACS

Professor of Otolaryngology - Head & Neck Surgery (OHNS)


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

   - Pregnant or suspected to be pregnant


device: Transoral robotic surgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305