©2022 Stanford Medicine
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)
Chris Holsinger, MD, FACS
Professor of Otolaryngology - Head & Neck Surgery (OHNS)
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