To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Primary performance: The primary endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted thoracic procedure without conversion to an alternate approach. Conversion to an alternate approach comprises undocking of the da Vinci SP to complete the planned procedures using other methods, such as open, VATS, or multiport robotic (da Vinci SI or X/Xi) Primary Safety: The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Rate of Conversion
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
Time frame: Intra-operative period
Major Adverse Event Rate
Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Time frame: Intra-operative through the 30 days follow-up period
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Duke University Hospital
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States