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

Completed · Not applicable

Conditions studied: Oropharyngeal Cancer

In brief

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

Key facts

Study ID

NCT03049280

Run by

Intuitive Surgical

People needed

33

Starts

2017-04-17

Expected to finish

2017-12-26

Last updated by the study team

2020-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Board of Trustees of the Leland Stanford Junior University — Palo Alto, California, United States
• Florida Hospital — Celebration, Florida, United States
• Trustees of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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