Clinical Trials

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.