Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intuitive Surgical
A prospective, multicenter investigation to evaluate the safety and clinical performance of the da Vinci SP Surgical System, instruments, and accessories in TORS procedures for malignant oropharyngeal tumors classified as T1 and T2.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
