Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Trial ID or NCT#
NCT03049280
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Chris Holsinger, MD, FACS
Head and neck surgeon
Professor of Otolaryngology - Head & Neck Surgery (OHNS)
View on ClinicalTrials.gov
