A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Transoral robotic surgery for T1 \& T2 oropharyngeal cancers
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
Performance
Performance defined as the conversion to an open approach required to complete the procedure
Time frame: Intraoperative
Number of Subjects With Device-related Serious Adverse Events
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Time frame: Intraoperative period
Positive Surgical Margin
Rate of final positive surgical margins confirmed by pathology
Time frame: Through14-days postoperatively
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