da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Korábbi kezelés

• Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
• Subject is contraindicated for general anesthesia or surgery
• Subject had prior incisional hernia with mesh repair

Más betegség

• Clinical or radiological evidence of metastatic disease
• Cancer of the anal canal requiring an abdominoperineal resection
• 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

Egyéb

• Life expectancy less than 6 months
• Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
• Subjects undergoing both LAR/TME and right colectomy during the same operation
• 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

• 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