To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Primary Performance: * The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. * Performing an extracorporeal anastomosis is not considered a conversion \*\* Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance Primary Safety: • The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
60
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision
Adventist Health System/Sunbelt
Orlando, Florida, United States
Henry Ford
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
MountianView Hospital
Las Vegas, Nevada, United States
Performance
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Time frame: IntraOperative period
Adverse Events Rates
Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Time frame: Intraoperative through the 42-day postoperative period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Houston Methodist Research Institute
Houston, Texas, United States
MultiCare - Tacoma
Tacoma, Washington, United States
Ulsan University Hospital
Ulsan, Dong-gu, South Korea
Ewha Womans University College of Medicine
Seoul, Gangseo-gu, South Korea