Robotic Assisted Surgery for Colorectal Cancer

Palo Alto (17 mi)

Overseen byDavid Larson, MD, MBA

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Intuitive Surgical

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

Eligibility Criteria

Adults with colorectal cancer who need complex surgery and have a BMI ≤ 35, ASA score ≤ 3 (indicating they're fit for surgery), and no widespread cancer. They must be able to follow the study plan, including visits up to 5 years after surgery.

Inclusion Criteria

I can follow the study's schedule for check-ups and long-term follow-up for 5 years.

I am 18 years old or older.

Exclusion Criteria

I am having surgery for both lower rectum cancer and right colon cancer at the same time.

I am scheduled for or might need a major surgery soon.

My colonoscopy showed I have cancer in different parts of my colon at the same time.

I do not have any uncontrolled illnesses that could affect my participation.

My anal canal cancer needs surgery involving abdomen and perineum removal.

I have a history of inflammatory bowel disease.

My scans show very close cancer margins near my rectum.

I cannot undergo surgery or general anesthesia due to health risks.

My cancer has spread to other parts of my body.

I had surgery before to fix a hernia with mesh.

I have a condition that affects my blood's ability to clot.

Treatment Details

The trial is testing the safety and performance of the da Vinci SP Surgical System in single-port robotic-assisted surgeries like low anterior resections or right colectomies for colorectal cancer.

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

Colorectal procedure will be performed by da Vinci SP® Surgical System

da Vinci SP Surgical System is already approved in United States for the following indications:

🇺🇸 Approved in United States as da Vinci SP Surgical System for:

Urological procedures including radical prostatectomy, pyeloplasty, nephrectomy, partial nephrectomy
Simple prostatectomy for benign prostatic hyperplasia (BPH) or enlarged prostate
Transvesical approach to simple and radical prostatectomy