Recruiting

Robotic Technology

Sponsor:

UCLA

Code:

NCT05321134

Conditions

Colo-rectal Cancer

Rectal Prolapse

Colostomy Stoma

Colorectal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single port robotic colorectal surgical procedure

Study Details

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.

Conditions

Colo-rectal Cancer

Rectal Prolapse

Colostomy Stoma

Colorectal Disorders

Study ID

NCT05321134

Start date

Apr 28, 2022

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Port Robotic Surgery Arm

Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system

Interventions

Single port robotic colorectal surgical procedure

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.

Primary outcome measure

  • Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Ankit Sarin, MD

9167034472axsarin@ucdavis.edu

Pallavi Vaidya, BPharm

9167346609pmvaidya@ucdavis.edu

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

More Information

Sponsor

University of California, Davis

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • robotic surgery
  • colorectal surgery
  • single port
  • Intuitive SP platform

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-05-29.