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Colo-rectal CancerCancerDevice

What this study is

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

What's being tested

  • Single port robotic colorectal surgical procedure

    Intervention · DEVICE

    After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations.

Study details

Sponsor
University of California, Davis
Conditions
Colo-rectal Cancer · Rectal Prolapse · Colostomy Stoma · Colorectal Disorders
Enrolling
25 people
Starts
2022-04-28
Est. completion
2028-04
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗