da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

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.

Primary Performance:

• The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.

  • Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance

Primary Safety:

• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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