da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Running, not enrolling · Not applicable

Conditions studied: Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors

In brief

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.

Key facts

Study ID

NCT04403022

Run by

Intuitive Surgical

People needed

60

Starts

2021-06-03

Expected to finish

2028-11-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• BMI ≤ 35
• Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
• ASA ≤ 3
• Willing and able to provide a written informed consent document
• Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years

You may not qualify if…

• Clinical or radiological evidence of metastatic disease
• Life expectancy less than 6 months
• Cancer of the anal canal requiring an abdominoperineal resection
• Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
• Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
• Subjects undergoing both LAR/TME and right colectomy during the same operation
• Preoperative colonoscopy demonstrating synchronous colorectal cancer
• History of inflammatory bowel disease
• Subject has a known bleeding or clotting disorder
• Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Subject is contraindicated for general anesthesia or surgery
• Subject had prior incisional hernia with mesh repair
• Subject belongs to vulnerable population
• Subject is pregnant or suspected to be pregnant
• Intraoperative Exclusion Criteria:
• Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure

Where it is running

• Adventist Health System/Sunbelt — Orlando, Florida, United States
• Henry Ford — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• MountianView Hospital — Las Vegas, Nevada, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• MultiCare - Tacoma — Tacoma, Washington, United States
• Ulsan University Hospital — Ulsan, Dong-gu, South Korea
• Ewha Womans University College of Medicine — Seoul, Gangseo-gu, South Korea

Full record on ClinicalTrials.gov

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