NCT05321134 Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
| NCT ID | NCT05321134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Colo-rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2022-04-28 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ankit Sarin, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT05321134 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colo-rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05321134 currently recruiting?
Yes, NCT05321134 is actively recruiting participants. Contact the research team at axsarin@ucdavis.edu for enrollment information.
Where is the NCT05321134 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT05321134 clinical trial?
NCT05321134 is sponsored by University of California, Davis. The principal investigator is Ankit Sarin, MD at University of California, Davis. The trial plans to enroll 25 participants.
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