Spots Global Cancer Trial Database for da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
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Trial Identification
Brief Title: da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Official Title: A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Study ID: NCT04403022
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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, Korea, Republic of
Ewha Womans University College of Medicine, Seoul, Gangseo-gu, Korea, Republic of
Contact Details
Name: Kathryn Wine
Affiliation: Medical Affairs Director
Role: STUDY_DIRECTOR
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