About this trial
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.
Eligibility criteria
Qualifiers
The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months prior to use of study product. To be considered to be not of childbearing potential, the subject must be postmenopausal for at least 2 years; have had a hysterectomy or bilateral tubal ligation, or be proven to be otherwise incapable of pregnancy. If of childbearing potential, the subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry and agree to continue practicing it during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spouse/partner sterility; or is practicing abstinence and agrees to continue abstinence or to start an acceptable method of contraception from the above list if sexual activity commences.
There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.
For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous adenomas, and localized neuroendocrine tumors) distal to 15 cm from the anal verge.
The subject is in good general health as evidenced by medical history and physical examination
Disqualifiers
The subject is child less than 18 years of age
The subject is a female who is pregnant or lactating
The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).
The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)
Trial design
Treatments tested in this trial
- Single port robotic colorectal surgical procedure
Treatment groups
Sponsors and collaborators
University of California, Davis
Lead sponsor
University of California, San Francisco
Collaborator
Yale University
Collaborator
Henry Ford Hospital
Collaborator
University of Massachusetts, Worcester
Collaborator