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

Not Recruiting

Trial ID: NCT03049280

Purpose

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)

Eligibility

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

Intervention(s):

device: Transoral robotic surgery

Not Recruiting

Contact Information

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