This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
53
Subjects scheduled to undergo robotic-assisted surgery
Orlando Health, Inc.
Orlando, Florida, United States
Sparrow Health System
Lansing, Michigan, United States
The Valley Hospital
Ridgewood, New Jersey, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Incidence of conversion
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
Time frame: Intra-operative
Incidence of adverse events
Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Time frame: 30-day follow-up
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