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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UC Davis Medical Center
RECRUITING
Sacramento
Contact Information
Primary
Ankit Sarin, MD
axsarin@ucdavis.edu
9167034472
Backup
Pallavi Vaidya, BPharm
pmvaidya@ucdavis.edu
9167346609
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2028-04
Participants
Target number of participants: 25
Treatments
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
Sponsors
Collaborators: Yale University, University of Massachusetts, Worcester, Henry Ford Hospital, University of California, San Francisco
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov