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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT05321134
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Single port robotic colorectal surgical procedure — 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.

Study Details

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.

Key Dates

Start date
Apr 28, 2022
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Ankit Sarin, MD

Find similar trials in Sacramento, CA

By research site
UC Davis Medical Center· Sacramento, CA

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