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

NCT ID: NCT05321134

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2028-04-30

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.

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 novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.

AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.

AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.

Conditions

Colo-rectal Cancer; Rectal Prolapse; Colostomy Stoma; Colorectal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Single port robotic colorectal surgical procedure

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Henry Ford Hospital

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ankit Sarin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Medical Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ankit Sarin, MD

Role: CONTACT

axsarin@ucdavis.edu

9167034472

Pallavi Vaidya, BPharm

Role: CONTACT

pmvaidya@ucdavis.edu

9167346609

Facility Contacts

Ankit Sarin, MD

Role: primary

References

Sarin A, Barnes KE, Shui AM, Nakamura Y, Hoffman DB, Romero-Hernandez F, Chern H. Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform. Dis Colon Rectum. 2024 Oct 1;67(10):e1600-e1606. doi: 10.1097/DCR.0000000000003352. Epub 2024 Sep 5.

Reference Type: DERIVED

PMID: 39250792 (View on PubMed)

Other Identifiers

2022178

Identifier Type: -

Identifier Source: org_study_id