Status:
RECRUITING
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
University of California, San Francisco
Yale University
Conditions:
Colo-rectal Cancer
Rectal Prolapse
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 a...
Detailed Description
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the n...
Eligibility Criteria
Inclusion
- 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
- The subject is able and willing to provide written informed consent.
- The subject agrees to comply with the requirements of the protocol and complete study measures.
- The subject has stable residence and telephone.
Exclusion
- 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)
- The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the investigator precludes participation.
- The subject has advanced/ Stage IV cancer
- The subject has received neo-adjuvant chemotherapy or radiation therapy
- The subject requires an emergency operation.
- The subject is unable to fully comprehend or consent to the study
- The subject is unwilling to be available for follow-up assessments.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05321134
Start Date
April 28 2022
End Date
April 1 2028
Last Update
December 5 2025
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817