A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
Primary Effectiveness Endpoint: • Ability to complete procedure without a need for conversion to a non-robotic approach Safety Endpoint: Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality Additional endpoints evaluated may include: * Procedure times * Length of hospital stay * Volume of tissue resected * Use of tissue sealants
Study Type
OBSERVATIONAL
Enrollment
285
Middlesex Hospital
Middletown, Connecticut, United States
St. Jose Mercey Health System
Ypsilanti, Michigan, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Primary Effectiveness Endpoint
Ability to complete procedure without a need for conversion to a non-robotic approach
Time frame: intra-operative
Primary Safety endpoint
Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality
Time frame: up to 30 days after surgery
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