A Study to Investigate the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

Overview

NCT ID: NCT04403022
Sponsor Protocol Number: dV SP – CR-01

About this study

The purpose of this study is 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.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • BMI ≤ 35.
  • Candidate for single-port robotic-assisted surgery for colorectal disease.
  • Malignant tumor or neoplastic polyps that is/are amenable for low anterior resection with or without total mesorectal excision or tumor specific total mesorectal excision depending on tumor height.
  • ASA ≤ 3.
  • Willing and able to provide a written informed consent document.
  • Willing and able to comply with the study protocol requirements  

Exclusion Criteria:

  • Clinical or radiological evidence of metastatic disease.
  • Life expectancy less than 6 months.  
  • Cancer of the anal canal requiring an abdominoperineal resection.
  • Severely symptomatic tumors.
  • Prior history of colon or rectal resection for benign or malignant causes, excluding appendectomy.
  • Preoperative colonoscopy demonstrating synchronous colorectal cancer.
  • History of inflammatory bowel disease.
  • History of prior prostatectomy.  
  • Known bleeding or clotting disorder.
  • Uncontrolled illness.
  • Contraindicated for general anesthesia or surgery.  
  • Subject belongs to vulnerable population.

More information

Publications

Publications are currently not available