Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

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

25 Participants
are divided into 1 treatment group

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